Glovatex White Latex Gloves, Glovanil Blue Nitrile Gloves
Device Facts
| Record ID | K213775 |
|---|---|
| Device Name | Glovatex White Latex Gloves, Glovanil Blue Nitrile Gloves |
| Applicant | Avecena Gloves Sdn Bhd |
| Product Code | LYY · General Hospital |
| Decision Date | Apr 24, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6250 |
| Device Class | Class 1 |
Indications for Use
The Glovatex™ White Latex Glove is a disposable device intended for Medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner. The Glovanil™ Blue Nitrile Glove is a disposable device intended for Medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner.
Device Story
Disposable patient examination gloves; Glovatex™ (natural rubber latex) and Glovanil™ (nitrile compound). Used by clinicians/examiners in medical settings to prevent cross-contamination between patient and examiner. Non-sterile, powder-free, single-use. Subject to standard physical property and biocompatibility testing to ensure safety and effectiveness equivalent to predicate devices.
Clinical Evidence
Bench testing only. No clinical data. Testing included physical properties (tensile strength, elongation), freedom from holes (ASTM D5151-19), powder residue (ASTM D6124-06/2017), and biocompatibility (cytotoxicity, irritation, sensitization, pyrogenicity) per ISO 10993 standards.
Technological Characteristics
Glovatex™: Natural rubber latex, white, non-sterile, powder-free. Glovanil™: Nitrile compound, blue, non-sterile, powder-free. Both meet ASTM D3578-19 (latex) or ASTM D6319-19 (nitrile) and ASTM D6124-06/2017. Biocompatibility per ISO 10993-5, -10, -11.
Indications for Use
Indicated for use as a disposable medical glove worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
Regulatory Classification
Identification
A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.
Predicate Devices
- Blue Latex Examination Powder Free Gloves (K192329)
- Powder Free Nitrile Examination Glove (Aqua Green) (K200326)
Related Devices
- K221667 — Non Sterile Powder Free Latex Examination Glove · New Era Medicare Sdn. Bhd. · Oct 28, 2022
- K972291 — ALLEGIANCE NON STERILE POWDER FREE LOW PROTEIN LATEX EXAMIATION GLOVES · Allegiance Healthcare Corp. · Jul 28, 1997
- K112928 — RS SAFE WHITE NITRILE MEDICAL EXAMINATION GLOVES POWDER FREE OR OTHER PROPRIETARY NAME · Riverstone Resources Sdn Bhd · Apr 17, 2012
- K022619 — POWDER FREE NITRILE EXAMINATION GLOVES · Ar Alliance Healthcare Sdn. Bhd. · Sep 6, 2002
- K202377 — Palm Care Latex Examination Powder Free Gloves · Hi-Care Thai Gloves Co. , Ltd. · Dec 1, 2020
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 24, 2022
Avecena Gloves Sdn Bhd % Mehmet Ormeci Consultant MEDCER Uluslararasi Medikal Belgelendirme Anonim Sirketi Mevlana Bulvari No:221/141 Yildirim Kule Ankara, Ankara 06830 Turkey
Re: K213775
Trade/Device Name: Glovatex™ White Latex Gloves, Glovanil™ Blue Nitrile Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYY.LZA Dated: March 24, 2022 Received: April 8, 2022
Dear Mehmet Ormeci:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K213775
Device Name
GlovatexTM White Latex Gloves, Glovanil™ Blue Nitrile Gloves
Indications for Use (Describe)
The Glovatex™ White Latex Glove is a disposable device intended for Medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner.
The Glovanil™ Blue Nittile Glove is a disposable device intended for Medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner.
| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;"> <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="font-family: Arial, sans-serif;"> <input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
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## 510(k) Summary K213775
| 510(k) Submitter Name | AVECENA GLOVES SDN BHD |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Submitter Adress | Lot 50592 Sendayan Techvalley Bandar Sri Sendayan Seremban NEGERI<br>SEMBILAN 71950 NEGERI SEMBILAN, Negeri Sembilan, 71950, MALAYSIA |
| 510(k) Submitter Telephone No | +60 - 193 - 477659 |
| Primary Correspondent Contact Information | Mehmet Fatih Ormeci (Consultant)<br>+90-532-397-3043<br>mformeci@gmail.com<br>Fax: +90-312-436-08-44 |
| Summary Preparation Date | 03/24/2022 |
| Trade Or<br>Proprietary Name | - | Glovatex™ White Latex Gloves<br>Glovanil™ Blue Nitrile Gloves |
|------------------------------|---|------------------------------------------------------------------------------------|
| Common Name | - | Latex patient examination glove powder free<br>- Polymer patient examination glove |
| Classification Name | | Non-powder patient examination glove |
| Class | | Class I reserved |
| Product Code | | LYY, LZA |
| | Subject Device 510k<br>No | Predicate Device 510k<br>No | Predicate Device<br>Manufacturer |
|-----------------------------------|---------------------------|-----------------------------|----------------------------------------------------------|
| GlovatexTM White<br>Latex Gloves | K213775 | K192329 | JR Engineering &<br>Medical Technologies<br>(M) SDN.BHD. |
| GlovanilTM Blue Nitrile<br>Gloves | K213775 | K200326 | Riverstone Resource<br>Sdn Bhd. |
### Device Description
Glovatex™ White Latex Gloves are manufactured to meet all the current specifications listed under the ASTM Specification D 3578-05 (Reapproved 2015), Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are in white color, non-sterile and powder free.
Glovanil™ Blue Nitrile Gloves are manufactured to meet all the current specifications listed under the ASTM Specification ASTM D6319 - 19 Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from Nitrile compound. These gloves are in Blue color, non-sterile and powder free.
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# Indications For Use/Intended Use Of The Device
The Glovatex™ White Latex Glove is a disposable device intended for Medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner.
The Glovanil™ Blue Nitrile Glove is a disposable device intended for Medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner.
## Technological Characteristics White Latex Gloves
| Characteristics | Standards | Device Performance | | | Comparison |
|---------------------------------------------------|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|---------------|
| | | Predicate | | Subject | |
| 510(k) number | - | K192329 | | K213775 | - |
| Manufacturer(s) | - | JR Engineering &<br>Medical<br>Technologies (M)<br>SDN.BHD. | | AVECENA GLOVES SDN<br>BHD | - |
| Name of device | - | Blue Latex<br>Examination Powder<br>Free Gloves | | Glovatex™ White Latex<br>Gloves | - |
| Product Code | - | LYY | | LYY | same |
| Dimensions-<br>Length | ASTM D3578<br>- 19<br>Clause 8.4 | Length > 220 mm (small)<br>Length > 220 mm (medium, large, X-large) | | | Similar |
| | | Size | Average | Size | Average |
| | | Small | 304 | Small | 245 |
| | | Medium | 304 | Medium | 245.6 |
| | | Large | 305 | Large | 247.5 |
| | | X-Large | 305 | X-Large | 244.3 |
| | | XX-Large | 305 | | Not available |
| Dimensions-<br>Width | ASTM D3578<br>- 19<br>Clause 8.4 | Width 70-90mm (small)<br>Width 85-105mm (medium)<br>Width 101-121mm (large)<br>Width 110-130mm (X-large) | | | Similar |
| | | Small | 84 | Small | 84.4 |
| | | Medium | 94 | Medium | 95.3 |
| | | Large | 105 | Large | 103.7 |
| | | X-Large | 114 | X-Large | 111.5 |
| | | XX-Large | 123 | | Not available |
| Dimensions-<br>Thickness -<br>Finger | ASTM D3578<br>- 19<br>Clause 8.4 | Finger > 0.08 mm | | Finger > 0.08 mm | Similar |
| | | Small | 0.38 | Small | 0.14 |
| | | Medium | 0.38 | Medium | 0.14 |
| | | Large | 0.38 | Large | 0.15 |
| | | X-Large | 0.38 | X-Large | 0.15 |
| | | XX-Large | 0.38 | | Not available |
| Dimensions-<br>Thickness -<br>Finger | ASTM D3578<br>- 19<br>Clause 8.4 | Palm > 0.08 mm | | Palm > 0.08 mm | Similar |
| | | Small | 0.31 | Small | 0.12 |
| | | Medium | 0.31 | Medium | 0.11 |
| | | Large | 0.31 | Large | 0.11 |
| | | X-Large | 0.31 | X-Large | 0.12 |
| Characteristics | Standards | Device Performance | | Comparison | |
| Physical<br>Properties-<br>Tensile Strength | ASTM D3578<br>- 19<br>Clause 8.5.1 | Predicate | Subject | Similar | |
| | | XX-Large 0.31 | Not available | | |
| | | Before Ageing<br>Tensile Strength > 18<br>Mpa | Before Ageing<br>Tensile Strength > 18<br>Mpa | | |
| | | Small 33<br>Medium 32.9<br>Large 32.2<br>X-Large 31.9<br>XX-Large 31.1 | Small 24.6<br>Medium 23.1<br>Large 23.7<br>X-Large 22<br>Not available | | |
| | | | | | |
| Physical<br>Properties-<br>Tensile Strength | ASTM D3578<br>- 19<br>Clause 8.5.2 | After Ageing<br>Tensile Strength > 14<br>Mpa | After Ageing<br>Tensile Strength > 14<br>Mpa | Similar | |
| | | Small 30<br>Medium 30.6<br>Large 29.9<br>X-Large 29.7<br>XX-Large 28.2 | Small 23.6<br>Medium 21.8<br>Large 20.9<br>X-Large 22.6<br>Not available | | |
| | | | | | |
| | | | | | |
| | | | | | |
| Physical<br>Properties-<br>Elongation at<br>Break | ASTM D3578<br>- 19<br>Clause 8.5.1 | Before Ageing<br>Ultimate Elongation<br>> 650% | Before Ageing<br>Ultimate Elongation<br>> 650% | Similar | |
| | | Small 1322<br>Medium 1250<br>Large 1392<br>X-Large 1130<br>XX-Large 1149 | Small 1316<br>Medium 1346<br>Large 1330<br>X-Large 1239<br>Not available | | |
| | | | | | |
| | | | | | |
| | | | | | |
| Physical<br>Properties-<br>Elongation at<br>Break | ASTM D3578<br>- 19<br>Clause 8.5.2 | After Ageing<br>Ultimate Elongation<br>> 500% | After Ageing<br>Ultimate Elongation<br>> 500% | Similar | |
| | | Small 1046<br>Medium 1122<br>Large 1257<br>X-Large 1011<br>XX-Large 1110 | Small 1356<br>Medium 1385<br>Large 1371<br>X-Large 1340<br>Not available | | |
| | | | | | |
| | | | | | |
| | | | | | |
| Powder Free<br>Residue | ASTM D<br>6124-<br>06/2017 | ≤2 mg/glove | ≤2 mg/glove | Similar | |
| | | Small 0.20<br>Medium 0.21<br>Large 0.22<br>X-Large 0.22<br>XX-Large 0.23 | Small 0.39<br>Medium 0.35<br>Large 0.37<br>X-Large 0.42<br>Not available | | |
| | | | | | |
| | | | | | |
| | | | | | |
| Biocompatibility | In vitro<br>Cytotoxicity<br>ISO10993-5<br>:2009(E) | Non-cytotoxic | Non-cytotoxic | Same | |
| | | | | | |
| | | | | | |
| | | Primary Skin<br>Not-irritant | Not-irritant | | |
| Characteristics | Standards | Device Performance | | Comparison | |
| | | Predicate | Subject | | |
| | 10993-<br>10:2010(E)<br>Dermal<br>Sensitization-<br>ISO<br>10993-<br>10:2010(E) | Not-sensitizer | Not-sensitizer | | |
| | Material<br>mediated<br>Pyrogenicity<br>ISO 10993-<br>11:2017(E) /<br>USP<br>41<151> | Non-pyrogenic | Non-pyrogenic | | |
| Freedom From<br>Holes | ASTM D<br>5151-19 | Passes | Passes | Same | |
| Intended use | - | Blue Latex<br>Examination<br>Powder Free Gloves<br>are<br>disposable devices<br>intended<br>for medical purpose<br>that are<br>worn on the<br>examiner's hand<br>to<br>prevent<br>contamination<br>between patient and<br>examiner. | The Glovatex™ White<br>Latex Glove is a<br>disposable device<br>intended for Medical<br>purpose that is worn on<br>the examiner's hands or<br>finger to prevent<br>contamination patient<br>and examiner. | Same | |
| Material | - | Natural Latex | Natural Latex | Same | |
| Color | - | Blue | White | Different | |
| Texture | - | Finger Texture | Finger Texture | Same | |
| Size | ASTM D3578 – 19 | Small, Medium,<br>Large, X<br>Large & XX Large | Small, Medium, Large, X<br>Large | Similar | |
| Single Use | Medical<br>Glove<br>Guidance<br>Manual<br>- Labeling | Single Use | Single Use | Same | |
| Sterile/non<br>sterile | - | Non sterile | Non sterile | Same | |
| Powder/Powder<br>free | - | Powder free | Powder free | Same | |
| Label and<br>Labeling | FDA Label<br>requirements | Meets FDA's label<br>and labeling<br>requirements | Meets FDA's label<br>and labeling<br>requirements | Same | |
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Although dimensions, physical properties, powder free residue quantity are slightly different between the predicate device and subject device, both of devices comply with the requirements of ASTM D3578 – 19 and ASTM D 6124-06/2017. The predicate device and subject device has different colors. The predicate device has 5 sizes, on the contrary the subject device has only 4 sizes. The subject device does not include XL size. All other specifications are same between the subject device and predicate device.
#### Blue Nitrile Glove
| Characteristics | Standards | Device Performance | | Comparison | | | | | | | | | | | | | | | | | | | | | | | | |
|--------------------------------------|-------------------------------------|----------------------------------------------------------------------------------------------------------------|-------------------------------------|------------|--|--|--|--|--|--|--|--|--|--|--------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|
| | | Predicate | Subject | | | | | | | | | | | | | | | | | | | | | | | | | |
| 510(k) number | - | K200326 | | - | | | | | | | | | | | | | | | | | | | | | | | | |
| Manufacturer(s) | - | Riverstone Resource Sdn<br>Bhd. | AVECENA GLOVES<br>SDN BHD | - | | | | | | | | | | | | | | | | | | | | | | | | |
| Name of device | - | Powder Free Nitrile<br>Examination Glove (Aqua<br>Green) | The Glovanil™ Blue<br>Nitrile Glove | - | | | | | | | | | | | | | | | | | | | | | | | | |
| Product Code | - | LZA | LZA | same | | | | | | | | | | | | | | | | | | | | | | | | |
| Dimensions-<br>Length | ASTM D<br>6319-19<br>(Clause 7.4.2) | Length > 220 mm (small)<br>Length > 230 mm (medium, large, X-large) | | Similar | | | | | | | | | | | | | | | | | | | | | | | | |
| | | Size Average Small Meet the<br>requirements<br>of ASTM D<br>6319-19 Medium Large X-Large XX-Large | | | | | | | | | | | | | Size Average Small 239.5 Medium 239.7 Large 238.3 X-Large 239.3 XX-Large Not available | | | | | | | | | | | | | |
| Dimensions-<br>Width | ASTM D<br>6319-19<br>(Clause 7.4.3) | Width 70-90mm (small)<br>Width 85-105mm (medium)<br>Width 100-120mm (large)<br>Width 110-130mm (X-large) | | Similar | | | | | | | | | | | | | | | | | | | | | | | | |
| | | Size Average Small Meet the<br>requirements<br>of ASTM D<br>6319-19 Medium Large X-Large XX-Large | | | | | | | | | | | | | Size Average Small 81.7 Medium 88.8 Large 104.3 X-Large 111.3 XX-Large Not available | | | | | | | | | | | | | |
| Dimensions-<br>Thickness -<br>Finger | ASTM D<br>6319-19<br>(Clause 7.4.4) | Finger > 0.05 mm | Finger > 0.05 mm | Similar | | | | | | | | | | | | | | | | | | | | | | | | |
| | | Size Average Small Meet the<br>requirements<br>of ASTM D<br>6319-19 Medium Large X-Large XX-Large | | | | | | | | | | | | | Size Average Small 0.14 Medium 0.14 Large 0.14 X-Large 0.14 XX-Large Not available | | | | | | | | | | | | | |
| Dimensions-<br>Thickness -<br>Finger | ASTM D<br>6319-19<br>(Clause 7.4.4) | Palm > 0.05 mm | Palm > 0.05 mm | Similar | | | | | | | | | | | | | | | | | | | | | | | | |
| | | Size Average Small Meet the<br>requirements<br>of ASTM D<br>6319-19 Medium Large X-Large XX-Large | | | | | | | | | | | | | Size Average Small 0.11 Medium 0.10 Large 0.09 X-Large 0.10 XX-Large Not available | | | | | | | | | | | | | |
| | | Before Ageing | Before Ageing | Similar | | | | | | | | | | | | | | | | | | | | | | | | |
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| Characteristics | Standards | Device Performance | | Comparison | |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|---------|
| | | Predicate | Subject | | |
| Physical<br>Properties-<br>Tensile Strength | ASTM D<br>6319-19<br>(Clause 7.5.1) | Tensile Strength > 14<br>Mpa<br>Meet the<br>requirements<br>of ASTM D<br>6319-19 | Tensile Strength > 14<br>Mpa<br>Small<br>Medium<br>Large<br>X-Large<br>XX-Large | 707<br>819<br>824<br>840<br>Not available | |
| Physical<br>Properties-<br>Tensile Strength | ASTM D<br>6319-19<br>(Clause 7.5.1) | After Ageing<br>Tensile Strength > 14<br>Mpa<br>Meet the<br>requirements<br>of ASTM D<br>6319-19 | After Ageing<br>Tensile Strength > 14<br>Mpa<br>Small<br>Medium<br>Large<br>X-Large<br>XX-Large | 22.8<br>24.3<br>24.0<br>22.2<br>Not available | Similar |
| Physical<br>Properties-<br>Elongation at<br>Break | ASTM D<br>6319-19<br>(Clause 7.5.1) | Before Ageing<br>Ultimate Elongation<br>> 500%<br>Meet the<br>requirements<br>of ASTM D<br>6319-19 | Before Ageing<br>Ultimate Elongation<br>> 500%<br>Small<br>Medium<br>Large<br>X-Large<br>XX-Large | 791<br>848<br>835<br>852<br>Not available | Similar |
| Physical<br>Properties-<br>Elongation at<br>Break | ASTM D<br>6319-19<br>(Clause 7.5.1) | After Ageing<br>Ultimate Elongation<br>> 400%<br>Meet the<br>requirements<br>of ASTM D<br>6319-19 | After Ageing<br>Ultimate Elongation<br>> 400%<br>Small<br>Medium<br>Large<br>X-Large<br>XX-Large | 23.6<br>24.5<br>24.2<br>22.1<br>Not available | Similar |
| Powder Free<br>Residue | ASTM D<br>6124-<br>06/2017 | ≤2 mg/glove<br>Meet the<br>requirements<br>of ASTM D<br>6124-<br>06/2017 | ≤2 mg/glove<br>Small<br>Medium<br>Large<br>X-Large<br>XX-Large | 1.18<br>1.91<br>0.81<br>1.17<br>Not available | Similar |
| Biocompatibility | In vitro<br>Cytotoxicity<br>ISO10993-5<br>Primary Skin<br>Irritation-ISO<br>10993-10<br>Dermal<br>Sensitization-<br>ISO | No information | Non-cytotoxic | | Similar |
| | | Not-irritant | Not-irritant | | |
| | | Not-sensitizer | Not-sensitizer | | |
| Characteristics | Standards | Device Performance | | Comparison | |
| | | Predicate | Subject | | |
| | 10993-10<br>Acute<br>Systemic Test<br>ISO 10993-11 | Did not induce a systemic<br>toxicity | Did not induce a<br>systemic toxicity | | |
| | Material<br>mediated<br>Pyrogenicity<br>ISO 10993-<br>11/ USP<br>41<151> | / | Did not produce a<br>pyrogenic response | Different | |
| Freedom From<br>Holes | ASTM D<br>5151-19 | Passes | Passes | Same | |
| Intended use | - | A powder free patient<br>examination glove is a<br>disposable device<br>intended for medical<br>purposes that is worn<br>on the examiner's hand<br>or finger to prevent<br>contamination between<br>patient and examiner.<br>The device is for overthe-<br>counter use. | The GlovanilTM Blue<br>Nitrile Glove is a<br>disposable device<br>intended for Medical<br>purpose that is worn<br>on the examiner's<br>hands or finger to<br>prevent<br>contamination<br>patient and<br>examiner. | Same | |
| Material | - | Nitrile compound | Nitrile compound | Same | |
| Color | - | Aqua Green | Blue | Different | |
| Size | ASTM D6319 - 19 | Small, Medium, Large, X<br>Large & XX Large | Small, Medium,<br>Large, X<br>Large | Similar | |
| Single Use | Medical<br>Glove<br>Guidance<br>Manual<br>- Labeling | Single Use…
