How to properly interpret the markings on protective gloves used in medical facilities?

dr n. med. Katarzy­na Maj­da, lek.  Sła­womir Gondek
Skamex S.A.

 Summary

In med­ical facil­i­ties, numer­ous med­ical pro­ce­dures are per­formed dai­ly in direct con­tact with patients, as well as non-med­ical tasks such as sur­face dis­in­fec­tion, equip­ment dis­pos­al, or con­tact with patients’ bio­log­i­cal mate­r­i­al. There­fore, it is rec­om­mend­ed to use diag­nos­tic and pro­tec­tive gloves, marked as both med­ical devices and per­son­al pro­tec­tive equip­ment. It is cru­cial to select gloves with pro­tec­tive prop­er­ties that cov­er the actu­al haz­ards present in the med­ical facil­i­ty to ensure the work­er’s safe­ty.

Keywords:

med­ical and pro­tec­tive gloves ➧ Euro­pean stan­dards ➧ chem­i­cal sub­stances ➧ per­me­ation ➧ pic­tograms

In med­ical facil­i­ties, numer­ous med­ical pro­ce­dures are per­formed dai­ly in direct con­tact with patients, as well as non-med­ical pro­ce­dures such as sur­face dis­in­fec­tion, equip­ment dis­pos­al, or con­tact with patients’ bio­log­i­cal mate­r­i­al. There­fore, it is rec­om­mend­ed to use diag­nos­tic and pro­tec­tive gloves marked as both med­ical devices and per­son­al pro­tec­tive equip­ment. Man­u­fac­tur­ers of pro­fes­sion­al med­ical gloves, to be able to dou­ble-mark their gloves, are required to assess their com­pli­ance with the essen­tial require­ments of the direc­tives on med­ical devices and per­son­al pro­tec­tive equip­ment. The most appro­pri­ate method to demon­strate com­pli­ance with the essen­tial require­ments is to con­duct a series of tests described in the rel­e­vant Euro­pean stan­dards, name­ly EN 455–1, ‑2, ‑3, ‑4 (Direc­tive 93/42/EEC for med­ical devices) and EN 420, EN 374–1, ‑2, ‑3, EN 388 (Direc­tive 89/686/EEC on per­son­al pro­tec­tive equip­ment) (see Table 1).

Medical Gloves Marking

Med­ical diag­nos­tic gloves are clas­si­fied as Class I med­ical devices (non-inva­sive devices). For Class I devices, the man­u­fac­tur­er con­ducts the con­for­mi­ty assess­ment them­selves and may vol­un­tar­i­ly sub­mit to the eval­u­a­tion by a noti­fied body. In the case of per­son­al pro­tec­tive equip­ment, most avail­able diag­nos­tic gloves fall under Cat­e­go­ry III (com­plex design, high risk) of per­son­al pro­tec­tive equip­ment, and the con­for­mi­ty assess­ment is manda­to­ry and con­duct­ed by a noti­fied body, which issues the appro­pri­ate CE cer­tifi­cate. The Euro­pean stan­dards men­tioned above for med­ical gloves (Table 1) [1–4] have been devel­oped for prod­ucts used in health­care facil­i­ties dur­ing med­ical pro­ce­dures in con­tact with patients.

Standards for Medical Gloves

Poz.	Stan­dard Num­ber	Scope of the Stan­dard	Ref­er­ences
1	EN 455–1	Require­ments and Tests for Absence of Holes (AQL Lev­el)	1
2	EN 455–2	Require­ments and Tests for Phys­i­cal Prop­er­ties (e.g., length, width, ten­sile strength)	2
3	EN 455–3	Require­ments and Tests for Bio­log­i­cal Eval­u­a­tion (e.g., latex pro­tein lev­els, endo­tox­ins)	3
4	EN 455–4	Require­ments and Tests for Deter­min­ing Shelf Life	4
5	EN 420	Gen­er­al Require­ments for Pro­tec­tive Gloves, includ­ing Man­u­fac­tur­er Infor­ma­tion on Pack­ag­ing and Test Meth­ods for Length, pH Lev­el, etc.	5
6	EN 374–1	Gen­er­al Require­ments and Ref­er­ence to Oth­er Parts of EN 374	6
7	EN 374–2	Pro­tec­tion Against Microor­gan­isms – Method­ol­o­gy for Deter­min­ing Resis­tance to Pen­e­tra­tion	7
8	EN 374–3	Method­ol­o­gy for Deter­min­ing Resis­tance to Chem­i­cal Per­me­ation	8
9	EN 388	Pro­tec­tion Against Mechan­i­cal Haz­ards – Deter­min­ing Resis­tance to Punc­ture, Abra­sion, Tear, and Cut	0

Tab. 1. List of stan­dards for gloves dou­ble-marked as med­ical devices and per­son­al pro­tec­tive equip­ment [1–9].

Protective Gloves

In the case of stan­dards for pro­tec­tive gloves (Table 1) [5–9], the pos­si­bil­i­ty of using such med­ical gloves by health­care work­ers was not con­sid­ered dur­ing their con­struc­tion. Since 2010, it has been pos­si­ble to dou­ble-mark gloves, but no appro­pri­ate nor­ma­tive changes have been intro­duced. A per­fect exam­ple of this is the unchanged list of 12 sub­stances typ­i­cal­ly used in indus­try found in Annex A of EN 374–1 (Table 2). These sub­stances in their pure form are not used in hos­pi­tals.

The lack of adap­ta­tion of tech­ni­cal stan­dards to the require­ments of the health­care envi­ron­ment has led to the con­tentious nature of point 5.3.2 of the EN 374–1 stan­dard, as its ful­fill­ment is inad­e­quate for actu­al use. The men­tioned sec­tion includes a pro­vi­sion requir­ing gloves to achieve the sec­ond lev­el of pro­tec­tion in test­ing using at least three sub­stances from the list of indus­tri­al sub­stances in Annex A (Table 2).

See rękaw­icz­ki nit­ry­lowe sem­per­care

Code Let­ter	Sub­stanc­ja chemicz­na	Class
A	Methanol	Pri­ma­ry Alco­hol
B	Ace­tone	Ketone
C	Ace­toni­trile	Nitrile Com­pound
D	Dichloromethane	Chlo­ri­nat­ed Alka­ne
E	Car­bon Disul­fide	Organ­ic Sul­fur Com­pound
F	Toluene	Aro­mat­ic Hydro­car­bon
G	Diethy­lamine	Chlo­ri­nat­ed Alka­ne
H	Tetrahy­dro­fu­ran	Het­e­ro­cyclic and Ether Com­pound
I	Eth­yl Acetate	Ester
J	n‑Heptane	Sat­u­rat­ed Hydro­car­bon
K	Sodi­um Hydrox­ide 40%	Inor­gan­ic Base
L	Sul­fu­ric Acid 96%	Inor­gan­ic Acid

 Tab. 2The list of sub­stances from Annex A of the EN 374–1 stan­dard (cur­rent ver­sion) [6].

Medical gloves standardization

The Euro­pean Com­mit­tee for Stan­dard­iza­tion, aim­ing to uni­fy the inter­pre­ta­tion of stan­dard pro­vi­sions, through the Pol­ish Com­mit­tee for Stan­dard­iza­tion, sent a let­ter to the largest dis­trib­u­tors of med­ical-pro­tec­tive gloves in Poland. Accord­ing to this doc­u­ment, the EN 374 stan­dard is con­sid­ered ful­ly met, both if point 5.3.2 is met and if it is exclud­ed [10]. Noti­fied bod­ies as exec­u­tive bod­ies have adopt­ed this prin­ci­ple, issu­ing appro­pri­ate cer­tifi­cates for Cat­e­go­ry III per­son­al pro­tec­tive equip­ment in both cas­es; oth­er­wise, issu­ing such a cer­tifi­cate would be impos­si­ble.

It is also worth empha­siz­ing that meet­ing point 5.3.2 of the EN 374–1 stan­dard may have lit­tle to do with actu­al pro­tec­tion against fac­tors pos­ing a threat to health­care work­ers. The process of chem­i­cal per­me­ation through med­ical gloves depends on many fac­tors. As a result, gloves pro­tect­ing against sub­stances from Annex A may often not pro­vide suf­fi­cient pro­tec­tion against sub­stances used in med­ical facil­i­ties (Table 3). Depend­ing on com­pli­ance with points 5.2.1 and/or 5.3.2 of the EN 374–1 stan­dard, med­ical gloves are marked with one of two pic­tograms (Fig. 1A and 1B). How­ev­er, the actu­al dif­fer­ence between the indi­cat­ed pic­tograms lies in meet­ing or exclud­ing point 5.3.2, and mis­lead­ing infor­ma­tion that may con­fuse users has appeared in the lit­er­a­ture. In the arti­cle by A. Trz­cińs­ka, the descrip­tion of the graph­i­cal sym­bol pre­sent­ed in Fig­ure 1B (Fig. 1 in the orig­i­nal) states “com­plete pro­tec­tion against chem­i­cal sub­stances” [11]. This can lead to over­in­ter­pre­ta­tion and cre­ate a false sense of secu­ri­ty when using a prod­uct that does not pro­vide ade­quate pro­tec­tion, as there are no med­ical gloves that com­plete­ly pro­tect against all chem­i­cal sub­stances, as sug­gest­ed by the quot­ed descrip­tion of the pic­togram.

Due to the var­i­ous types of mate­ri­als from which gloves are made and the dif­fer­ent com­po­si­tions of chem­i­cal sub­stances, there are no stan­dard sub­stances whose test­ing would guar­an­tee pro­tec­tion against all pos­si­ble chem­i­cal agents. More­over, as shown above, the pro­tec­tion indi­cat­ed by a par­tic­u­lar pic­togram may be dis­pro­por­tion­ate to the actu­al expo­sure in some pro­fes­sion­al areas, such as health­care.

Types of medical gloves

Types of gloves	Sub­stances from Annex A of the EN 374–1 stan­dard			Sub­stances used in hos­pi­tals
		Diethy­lamine	Sodi­um hydrox­ide 40%	Sul­fu­ric acid 96%	Glu­taralde­hyde	Mit­o­mycin	Flu­o­rouracil
Gloves A	< 60 min	< 120 min	< 60 min	< 120 min	< 60 min	< 120 min
Gloves B	< 10 min	> 480 min	< 10 min	> 480 min	> 240 min	> 240 min
Gloves C	< 10 min	> 480 min	< 10 min	> 480 min	> 240 min	> 240 min

Medical Protective Gloves

It should be empha­sized that there is no con­tact with the sub­stances list­ed in Annex A of EN 374–1 in med­ical facil­i­ties. Sub­stances in their pure form are not present in hos­pi­tals, and more­over, rou­tine, fre­quent glove changes short­en the wear­ing time of med­ical gloves to a max­i­mum of about 30 min­utes. This time is half as short as that men­tioned in point 5.3.2 of EN 374–1 lev­el 2. Addi­tion­al­ly, the indi­cat­ed pro­tec­tion would only be nec­es­sary in the case of full immer­sion in a giv­en sub­stance for a spec­i­fied peri­od, which fur­ther con­firms that such a sit­u­a­tion is impos­si­ble in a health­care set­ting. The authors ful­ly agree with the fol­low­ing opin­ion of Trz­cińs­ka A.: “Most man­u­fac­tur­ers of med­ical-pro­tec­tive gloves test, in accor­dance with the method­ol­o­gy described in EN 374–3, their resis­tance to a range of sub­stances not list­ed in Annex A of EN 374. Test­ing of sub­stances out­side the annex enables deter­mi­na­tion of the actu­al lev­el of pro­tec­tion against sub­stances char­ac­ter­is­tic for a giv­en work area” [11]. By test­ing the resis­tance of med­ical-pro­tec­tive gloves to sub­stances actu­al­ly present in the med­ical envi­ron­ment, we are able to assess the real lev­el of pro­tec­tion for health­care work­ers in con­tact with them.

Ryc. 1. Pic­tograms indi­cat­ing pro­tec­tion against chem­i­cal sub­stances from Annex A, test­ed accord­ing to EN 374–3 stan­dard: A — in accor­dance with point 5.2.1 of EN 374–1; B — in accor­dance with points 5.2.1 and 5.3.2 of EN 374–1.

Medical gloves

It is impor­tant to remem­ber that med­ical pro­tec­tive gloves are prod­ucts designed for mass use in health­care facil­i­ties. Such gloves are pri­mar­i­ly intend­ed to pro­tect per­son­nel against micro­bi­o­log­i­cal haz­ards and chem­i­cal sub­stances encoun­tered on a dai­ly basis, such as those found in dis­in­fec­tants or cyto­sta­t­ics. In the con­text of exist­ing stan­dards, no glove used in med­i­cine pro­vides 100% pro­tec­tion against indus­tri­al sub­stances list­ed in Annex A of EN 374–1, just as no glove pro­vides mechan­i­cal pro­tec­tion accord­ing to EN 388 (lev­el 0 for resis­tance to punc­ture, tear, abra­sion, and cut). There­fore, it is essen­tial to select appro­pri­ate med­ical gloves accord­ing to their intend­ed use and expo­sure to real haz­ards.

 

Bibliography

1. EN 455–1 Rękaw­ice medy­czne do jed­no­ra­zowego użytku – Część 1: Wyma­gania i bada­nia na nieobec­ność dzi­ur.
2. EN 455–2 Rękaw­ice medy­czne jed­no­ra­zowego użytku – Część 2: Wyma­gania i bada­nia doty­czące właś­ci­woś­ci fizy­cznych.
3. EN 455–3 Rękaw­ice medy­czne jed­no­ra­zowego użytku – Część 3: Wyma­gania i bada­nia w oce­nie bio­log­icznej.
4. PN-EN 455–4 Rękaw­ice medy­czne do jed­no­ra­zowego użytku – Część 4: Wyma­gania i bada­nia doty­czące wyz­nacza­nia okre­su trwałoś­ci.
5. EN 420 Pro­tec­tive Gloves – Wyma­gania ogólne i metody badań, m.in. dostar­czane przez pro­du­cen­ta infor­ma­c­je, które mają zas­tosowanie do wszys­t­kich rękaw­ic ochron­nych.
6. EN 374–1 Rękaw­ice chroniące przed sub­stanc­ja­mi chemiczny­mi i mikroor­ga­niz­ma­mi – Część 1: Ter­mi­nolo­gia i wyma­gania.
7. EN 374–2 Rękaw­ice chroniące przed sub­stanc­ja­mi chemiczny­mi i mikroor­ga­niz­ma­mi – Część 2: Wyz­naczanie odpornoś­ci na prze­siąkanie.
8. EN 374–3 Rękaw­ice chroniące przed sub­stanc­ja­mi chemiczny­mi i mikroor­ga­niz­ma­mi – Część 3: Wyz­naczanie odpornoś­ci na przenikanie sub­stancji chemicznych.
9. EN 388 Rękaw­ice chroniące przed zagroże­ni­a­mi mechan­iczny­mi. 10. Pis­mo PKN na pod­staw­ie opinii Europe­jskiego Komite­tu Nor­mal­iza­cyjnego z 7.07.2016 r., adresowane do dys­try­b­u­torów rękaw­ic medyczno–ochronnych.
10. Trz­cińs­ka A.: Jakie wyma­gania (normy) powin­ny speł­ni­ać rękaw­icz­ki uży­wane w środowisku medy­cznym, aby mogły zapewnić użytkown­ikowi ochronę przed zagroże­ni­a­mi bio­log­iczny­mi i chemiczny­mi? Zakaże­nia 2016, 6.
11. Rękaw­ice medy­czne – wikipedia