(143 days)
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.
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.
This document is a 510(k) premarket notification for medical gloves, and as such, it does not describe an AI/ML device. Therefore, the questions related to AI/ML device performance (such as effect size, standalone performance, ground truth establishment, training set size, and expert qualifications for ground truth) are not applicable.
The document focuses on demonstrating substantial equivalence to predicate devices through physical and biocompatibility testing.
Here's the information extracted concerning the acceptance criteria and device performance for the two glove products described:
1. Table of Acceptance Criteria and Reported Device Performance
Glovatex™ White Latex Gloves (Predicate: K192329)
| Characteristics | Standards | Acceptance Criteria (from Standard) | Reported Device Performance (Subject Device) | Comparison to Predicate |
|---|---|---|---|---|
| Dimensions - Length (Small) | ASTM D3578-19, Clause 8.4 | > 220 mm | 245 mm | Similar to Predicate |
| Dimensions - Length (Medium) | ASTM D3578-19, Clause 8.4 | > 220 mm | 245.6 mm | Similar to Predicate |
| Dimensions - Length (Large) | ASTM D3578-19, Clause 8.4 | > 220 mm | 247.5 mm | Similar to Predicate |
| Dimensions - Length (X-Large) | ASTM D3578-19, Clause 8.4 | > 220 mm | 244.3 mm | Similar to Predicate |
| Dimensions - Width (Small) | ASTM D3578-19, Clause 8.4 | 70-90mm | 84.4 mm | Similar to Predicate |
| Dimensions - Width (Medium) | ASTM D3578-19, Clause 8.4 | 85-105mm | 95.3 mm | Similar to Predicate |
| Dimensions - Width (Large) | ASTM D3578-19, Clause 8.4 | 101-121mm | 103.7 mm | Similar to Predicate |
| Dimensions - Width (X-Large) | ASTM D3578-19, Clause 8.4 | 110-130mm | 111.5 mm | Similar to Predicate |
| Dimensions - Thickness - Finger | ASTM D3578-19, Clause 8.4 | > 0.08 mm | Small: 0.14, Medium: 0.14, Large: 0.15, X-Large: 0.15 mm | Similar to Predicate |
| Dimensions - Thickness - Palm | ASTM D3578-19, Clause 8.4 | > 0.08 mm | Small: 0.12, Medium: 0.11, Large: 0.11, X-Large: 0.12 mm | Similar to Predicate |
| Physical Properties - Tensile Strength (Before Ageing) | ASTM D3578-19, Clause 8.5.1 | > 18 Mpa | Small: 24.6, Medium: 23.1, Large: 23.7, X-Large: 22 Mpa | Similar to Predicate |
| Physical Properties - Tensile Strength (After Ageing) | ASTM D3578-19, Clause 8.5.2 | > 14 Mpa | Small: 23.6, Medium: 21.8, Large: 20.9, X-Large: 22.6 Mpa | Similar to Predicate |
| Physical Properties - Elongation at Break (Before Ageing) | ASTM D3578-19, Clause 8.5.1 | > 650% | Small: 1316, Medium: 1346, Large: 1330, X-Large: 1239 % | Similar to Predicate |
| Physical Properties - Elongation at Break (After Ageing) | ASTM D3578-19, Clause 8.5.2 | > 500% | Small: 1356, Medium: 1385, Large: 1371, X-Large: 1340 % | Similar to Predicate |
| Powder Free Residue | ASTM D6124-06/2017 | ≤ 2 mg/glove | Small: 0.39, Medium: 0.35, Large: 0.37, X-Large: 0.42 mg/glove | Similar to Predicate |
| Biocompatibility - In vitro Cytotoxicity | ISO10993-5:2009(E) | Non-cytotoxic | Non-cytotoxic | Same as Predicate |
| Biocompatibility - Primary Skin Irritation | ISO 10993-10:2010(E) | Not-irritant | Not-irritant | Same as Predicate |
| Biocompatibility - Dermal Sensitization | ISO 10993-10:2010(E) | Not-sensitizer | Not-sensitizer | Same as Predicate |
| Biocompatibility - Material mediated Pyrogenicity | ISO 10993-11:2017(E)/USP 41<151> | Non-pyrogenic | Non-pyrogenic | Same as Predicate |
| Freedom From Holes | ASTM D5151-19 | Passes | Passes | Same as Predicate |
| Intended Use | - | Prevent contamination between patient and examiner | Same | Same as Predicate |
| Material | - | Natural Latex | Natural Latex | Same as Predicate |
| Color | - | Blue (Predicate) | White (Subject) | Different from Predicate |
| Texture | - | Finger Texture | Finger Texture | Same as Predicate |
| Size | ASTM D3578-19 | Small, Medium, Large, X-Large, XX-Large | Small, Medium, Large, X-Large | Similar (XX-Large not available for subject) |
| Single Use | Medical Glove Guidance Manual - Labeling | Single Use | Single Use | Same as Predicate |
| Sterile/non-sterile | - | Non sterile | Non sterile | Same as Predicate |
| Powder/Powder free | - | Powder free | Powder free | Same as Predicate |
| Label and Labeling | FDA Label requirements | Meets FDA's label and labeling requirements | Meets FDA's label and labeling requirements | Same as Predicate |
Glovanil™ Blue Nitrile Gloves (Predicate: K200326)
| Characteristics | Standards | Acceptance Criteria (from Standard) | Reported Device Performance (Subject Device) | Comparison to Predicate |
|---|---|---|---|---|
| Dimensions - Length (Small) | ASTM D6319-19, Clause 7.4.2 | > 220 mm | 239.5 mm | Similar to Predicate |
| Dimensions - Length (Medium) | ASTM D6319-19, Clause 7.4.2 | > 230 mm | 239.7 mm | Similar to Predicate |
| Dimensions - Length (Large) | ASTM D6319-19, Clause 7.4.2 | > 230 mm | 238.3 mm | Similar to Predicate |
| Dimensions - Length (X-Large) | ASTM D6319-19, Clause 7.4.2 | > 230 mm | 239.3 mm | Similar to Predicate |
| Dimensions - Width (Small) | ASTM D6319-19, Clause 7.4.3 | 70-90mm | 81.7 mm | Similar to Predicate |
| Dimensions - Width (Medium) | ASTM D6319-19, Clause 7.4.3 | 85-105mm | 88.8 mm | Similar to Predicate |
| Dimensions - Width (Large) | ASTM D6319-19, Clause 7.4.3 | 100-120mm | 104.3 mm | Similar to Predicate |
| Dimensions - Width (X-Large) | ASTM D6319-19, Clause 7.4.3 | 110-130mm | 111.3 mm | Similar to Predicate |
| Dimensions - Thickness - Finger | ASTM D6319-19, Clause 7.4.4 | > 0.05 mm | Small: 0.14, Medium: 0.14, Large: 0.14, X-Large: 0.14 mm | Similar to Predicate |
| Dimensions - Thickness - Palm | ASTM D6319-19, Clause 7.4.4 | > 0.05 mm | Small: 0.11, Medium: 0.10, Large: 0.09, X-Large: 0.10 mm | Similar to Predicate |
| Physical Properties - Tensile Strength (Before Ageing) | ASTM D6319-19, Clause 7.5.1 | > 14 Mpa (Predicate met, Specific values not given for predicate.) | Small: 22.8, Medium: 24.3, Large: 24.0, X-Large: 22.2 Mpa | Similar to Predicate |
| Physical Properties - Tensile Strength (After Ageing) | ASTM D6319-19, Clause 7.5.1 | > 14 Mpa | Small: 22.8, Medium: 24.3, Large: 24.0, X-Large: 22.2 Mpa | Similar to Predicate |
| Physical Properties - Elongation at Break (Before Ageing) | ASTM D6319-19, Clause 7.5.1 | > 500% (Predicate met, Specific values not given for predicate.) | Small: 791, Medium: 848, Large: 835, X-Large: 852 % | Similar to Predicate |
| Physical Properties - Elongation at Break (After Ageing) | ASTM D6319-19, Clause 7.5.1 | > 400% | Small: 791, Medium: 848, Large: 835, X-Large: 852 % | Similar to Predicate |
| Powder Free Residue | ASTM D6124-06/2017 | ≤ 2 mg/glove | Small: 1.18, Medium: 1.91, Large: 0.81, X-Large: 1.17 mg/glove | Similar to Predicate |
| Biocompatibility - In vitro Cytotoxicity | ISO10993-5:2009(E) | Non-cytotoxic (Predicate: No information stated, Subject: Non-cytotoxic) | Non-cytotoxic | Similar to Predicate |
| Biocompatibility - Primary Skin Irritation | ISO 10993-10:2010(E) | Not-irritant | Not-irritant | Similar to Predicate |
| Biocompatibility - Dermal Sensitization | ISO 10993-10:2010(E) | Not-sensitizer | Not-sensitizer | Similar to Predicate |
| Biocompatibility - Acute Systemic Toxicity | ISO 10993-11:2017(E) | Did not induce a systemic toxicity | Did not induce a systemic toxicity | Similar to Predicate |
| Biocompatibility - Material mediated Pyrogenicity | ISO 10993-11:2017(E)/USP 41<151> | Non-pyrogenic (Predicate: N/A, Subject: Did not produce a pyrogenic response) | Did not produce a pyrogenic response | Different from Predicate (More testing for subject) |
| Freedom From Holes | ASTM D5151-19 | Passes | Passes | Same as Predicate |
| Intended Use | - | Prevent contamination between patient and examiner | Same | Same as Predicate |
| Material | - | Nitrile compound | Nitrile compound | Same as Predicate |
| Color | - | Aqua Green (Predicate) | Blue (Subject) | Different from Predicate |
| Size | ASTM D3578-19 | Small, Medium, Large, X-Large, XX-Large | Small, Medium, Large, X-Large | Similar (XX-Large not available for subject) |
| Single Use | Medical Glove Guidance Manual - Labeling | Single Use | Single Use | Same as Predicate |
| Sterile/non-sterile | - | Non sterile | Non sterile | Same as Predicate |
| Powder/Powder free | - | Powder free | Powder free | Same as Predicate |
| Label and Labeling | FDA Label requirements | Meets FDA's label and labeling requirements | Meets FDA's label and labeling requirements | Same as Predicate |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each physical and chemical test. It only provides the performance results (e.g., average length, tensile strenth values) across different glove sizes. The provenance of the data is from laboratory testing performed on the "subject device" (the Glovatex White Latex Gloves and Glovanil Blue Nitrile Gloves) to demonstrate compliance with referenced ASTM and ISO standards. This is prospective testing for the purpose of the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as this is not an AI/ML device study. Performance is measured against established industry standards (ASTM, ISO).
4. Adjudication method for the test set
Not applicable, as this is not an AI/ML device study requiring expert adjudication of outputs. Compliance is determined by whether the test results meet the numerical and qualitative specifications of the referenced standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable, as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI/ML device.
7. The type of ground truth used
The "ground truth" for the device performance is the set of specifications and requirements outlined in the referenced consensus standards:
- ASTM D3578-19 (Standard Specification for Rubber Examination Gloves)
- ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application)
- ASTM D6124-06/2017 (Standard Test Method for Residual Powder on Medical Gloves)
- ASTM D5151-19 (Standard Test Method for Detection of Holes in Medical Gloves)
- ISO 10993-5:2009(E) (Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity)
- ISO 10993-10:2010(E) (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization)
- ISO 10993-11:2017(E) (Biological evaluation of medical devices - Part 11: Tests for systemic toxicity)
- USP 41<151> (Pyrogen Test)
8. The sample size for the training set
Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device.
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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
{1}------------------------------------------------
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 NEGERISEMBILAN 71950 NEGERI SEMBILAN, Negeri Sembilan, 71950, MALAYSIA |
| 510(k) Submitter Telephone No | +60 - 193 - 477659 |
| Primary Correspondent Contact Information | Mehmet Fatih Ormeci (Consultant)+90-532-397-3043mformeci@gmail.comFax: +90-312-436-08-44 |
| Summary Preparation Date | 03/24/2022 |
| Trade OrProprietary Name | - | Glovatex™ White Latex GlovesGlovanil™ Blue Nitrile Gloves |
|---|---|---|
| Common Name | - | Latex patient examination glove powder free- Polymer patient examination glove |
| Classification Name | Non-powder patient examination glove | |
| Class | Class I reserved | |
| Product Code | LYY, LZA |
| Subject Device 510kNo | Predicate Device 510kNo | Predicate DeviceManufacturer | |
|---|---|---|---|
| GlovatexTM WhiteLatex Gloves | K213775 | K192329 | JR Engineering &Medical Technologies(M) SDN.BHD. |
| GlovanilTM Blue NitrileGloves | K213775 | K200326 | Riverstone ResourceSdn 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 &MedicalTechnologies (M)SDN.BHD. | AVECENA GLOVES SDNBHD | - | |
| Name of device | - | Blue LatexExamination PowderFree Gloves | Glovatex™ White LatexGloves | - | |
| Product Code | - | LYY | LYY | same | |
| Dimensions-Length | ASTM D3578- 19Clause 8.4 | Length > 220 mm (small)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-Width | ASTM D3578- 19Clause 8.4 | Width 70-90mm (small)Width 85-105mm (medium)Width 101-121mm (large)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-Thickness -Finger | ASTM D3578- 19Clause 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-Thickness -Finger | ASTM D3578- 19Clause 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 | ||
| PhysicalProperties-Tensile Strength | ASTM D3578- 19Clause 8.5.1 | Predicate | Subject | Similar | |
| XX-Large 0.31 | Not available | ||||
| Before AgeingTensile Strength > 18Mpa | Before AgeingTensile Strength > 18Mpa | ||||
| Small 33Medium 32.9Large 32.2X-Large 31.9XX-Large 31.1 | Small 24.6Medium 23.1Large 23.7X-Large 22Not available | ||||
| PhysicalProperties-Tensile Strength | ASTM D3578- 19Clause 8.5.2 | After AgeingTensile Strength > 14Mpa | After AgeingTensile Strength > 14Mpa | Similar | |
| Small 30Medium 30.6Large 29.9X-Large 29.7XX-Large 28.2 | Small 23.6Medium 21.8Large 20.9X-Large 22.6Not available | ||||
| PhysicalProperties-Elongation atBreak | ASTM D3578- 19Clause 8.5.1 | Before AgeingUltimate Elongation> 650% | Before AgeingUltimate Elongation> 650% | Similar | |
| Small 1322Medium 1250Large 1392X-Large 1130XX-Large 1149 | Small 1316Medium 1346Large 1330X-Large 1239Not available | ||||
| PhysicalProperties-Elongation atBreak | ASTM D3578- 19Clause 8.5.2 | After AgeingUltimate Elongation> 500% | After AgeingUltimate Elongation> 500% | Similar | |
| Small 1046Medium 1122Large 1257X-Large 1011XX-Large 1110 | Small 1356Medium 1385Large 1371X-Large 1340Not available | ||||
| Powder FreeResidue | ASTM D6124-06/2017 | ≤2 mg/glove | ≤2 mg/glove | Similar | |
| Small 0.20Medium 0.21Large 0.22X-Large 0.22XX-Large 0.23 | Small 0.39Medium 0.35Large 0.37X-Large 0.42Not available | ||||
| Biocompatibility | In vitroCytotoxicityISO10993-5:2009(E) | Non-cytotoxic | Non-cytotoxic | Same | |
| Primary SkinNot-irritant | Not-irritant | ||||
| Characteristics | Standards | Device Performance | Comparison | ||
| Predicate | Subject | ||||
| 10993-10:2010(E)DermalSensitization-ISO10993-10:2010(E) | Not-sensitizer | Not-sensitizer | |||
| MaterialmediatedPyrogenicityISO 10993-11:2017(E) /USP41<151> | Non-pyrogenic | Non-pyrogenic | |||
| Freedom FromHoles | ASTM D5151-19 | Passes | Passes | Same | |
| Intended use | - | Blue LatexExaminationPowder Free Glovesaredisposable devicesintendedfor medical purposethat areworn on theexaminer's handtopreventcontaminationbetween patient andexaminer. | The Glovatex™ WhiteLatex Glove is adisposable deviceintended for Medicalpurpose that is worn onthe examiner's hands orfinger to preventcontamination patientand examiner. | Same | |
| Material | - | Natural Latex | Natural Latex | Same | |
| Color | - | Blue | White | Different | |
| Texture | - | Finger Texture | Finger Texture | Same | |
| Size | ASTM D3578 – 19 | Small, Medium,Large, XLarge & XX Large | Small, Medium, Large, XLarge | Similar | |
| Single Use | MedicalGloveGuidanceManual- Labeling | Single Use | Single Use | Same | |
| Sterile/nonsterile | - | Non sterile | Non sterile | Same | |
| Powder/Powderfree | - | Powder free | Powder free | Same | |
| Label andLabeling | FDA Labelrequirements | Meets FDA's labeland labelingrequirements | Meets FDA's labeland labelingrequirements | 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 SdnBhd. | AVECENA GLOVESSDN BHD | - | ||||||||||||||||||||||||
| Name of device | - | Powder Free NitrileExamination Glove (AquaGreen) | The Glovanil™ BlueNitrile Glove | - | ||||||||||||||||||||||||
| Product Code | - | LZA | LZA | same | ||||||||||||||||||||||||
| Dimensions-Length | ASTM D6319-19(Clause 7.4.2) | Length > 220 mm (small)Length > 230 mm (medium, large, X-large) | Similar | |||||||||||||||||||||||||
| Size Average Small Meet therequirementsof ASTM D6319-19 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-Width | ASTM D6319-19(Clause 7.4.3) | Width 70-90mm (small)Width 85-105mm (medium)Width 100-120mm (large)Width 110-130mm (X-large) | Similar | |||||||||||||||||||||||||
| Size Average Small Meet therequirementsof ASTM D6319-19 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-Thickness -Finger | ASTM D6319-19(Clause 7.4.4) | Finger > 0.05 mm | Finger > 0.05 mm | Similar | ||||||||||||||||||||||||
| Size Average Small Meet therequirementsof ASTM D6319-19 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-Thickness -Finger | ASTM D6319-19(Clause 7.4.4) | Palm > 0.05 mm | Palm > 0.05 mm | Similar | ||||||||||||||||||||||||
| Size Average Small Meet therequirementsof ASTM D6319-19 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 | ||||
| PhysicalProperties-Tensile Strength | ASTM D6319-19(Clause 7.5.1) | Tensile Strength > 14MpaMeet therequirementsof ASTM D6319-19 | Tensile Strength > 14MpaSmallMediumLargeX-LargeXX-Large | 707819824840Not available | |
| PhysicalProperties-Tensile Strength | ASTM D6319-19(Clause 7.5.1) | After AgeingTensile Strength > 14MpaMeet therequirementsof ASTM D6319-19 | After AgeingTensile Strength > 14MpaSmallMediumLargeX-LargeXX-Large | 22.824.324.022.2Not available | Similar |
| PhysicalProperties-Elongation atBreak | ASTM D6319-19(Clause 7.5.1) | Before AgeingUltimate Elongation> 500%Meet therequirementsof ASTM D6319-19 | Before AgeingUltimate Elongation> 500%SmallMediumLargeX-LargeXX-Large | 791848835852Not available | Similar |
| PhysicalProperties-Elongation atBreak | ASTM D6319-19(Clause 7.5.1) | After AgeingUltimate Elongation> 400%Meet therequirementsof ASTM D6319-19 | After AgeingUltimate Elongation> 400%SmallMediumLargeX-LargeXX-Large | 23.624.524.222.1Not available | Similar |
| Powder FreeResidue | ASTM D6124-06/2017 | ≤2 mg/gloveMeet therequirementsof ASTM D6124-06/2017 | ≤2 mg/gloveSmallMediumLargeX-LargeXX-Large | 1.181.910.811.17Not available | Similar |
| Biocompatibility | In vitroCytotoxicityISO10993-5Primary SkinIrritation-ISO10993-10DermalSensitization-ISO | No information | Non-cytotoxic | Similar | |
| Not-irritant | Not-irritant | ||||
| Not-sensitizer | Not-sensitizer | ||||
| Characteristics | Standards | Device Performance | Comparison | ||
| Predicate | Subject | ||||
| 10993-10AcuteSystemic TestISO 10993-11 | Did not induce a systemictoxicity | Did not induce asystemic toxicity | |||
| MaterialmediatedPyrogenicityISO 10993-11/ USP41<151> | / | Did not produce apyrogenic response | Different | ||
| Freedom FromHoles | ASTM D5151-19 | Passes | Passes | Same | |
| Intended use | - | A powder free patientexamination glove is adisposable deviceintended for medicalpurposes that is wornon the examiner's handor finger to preventcontamination betweenpatient and examiner.The device is for overthe-counter use. | The GlovanilTM BlueNitrile Glove is adisposable deviceintended for Medicalpurpose that is wornon the examiner'shands or finger topreventcontaminationpatient andexaminer. | Same | |
| Material | - | Nitrile compound | Nitrile compound | Same | |
| Color | - | Aqua Green | Blue | Different | |
| Size | ASTM D6319 - 19 | Small, Medium, Large, XLarge & XX Large | Small, Medium,Large, XLarge | Similar | |
| Single Use | MedicalGloveGuidanceManual- Labeling | Single Use | Single Use | Same | |
| Sterile/nonsterile | - | Non sterile | Non sterile | Same | |
| Powder/Powderfree | Powder free | Powder free | Same | ||
| Label andLabeling | FDA Labelrequirements | Meets FDA's labeland labelingrequirements | Meets FDA's labeland labelingrequirements | 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 D6319-10 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. More biocompatibility tests were performed to subject device compared to
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predicate device. Both devices meet the requirements of ISO 10993-1. All other specifications are same between the subject device and predicate devices.
Summary of Non-Clinical Testing
The Glovatex™ White Latex Gloves meet the requirements of ASTM D3578 - 19, ASTM D 6124-06(2017), ISO10993-5:2009(E), ISO 10993-10:2010(E), ISO 10993-11:2017(E), USP 41<151> and ASTM D 5151-19.
The Glovanil™ Blue Nitrile Gloves meet the requirements of ASTM D 6319-19, ASTM D 6124-06(2017), ISO10993-5:2009(E), ISO 10993-10:2010(E), ISO 10993-11:2017(E), USP 41<151> and ASTM D 5151-19.
Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the Glovatex™ White Latex Gloves is as safe, as effective, and performs as well as or better than the legally marketed predicate device K192329.
The conclusion drawn from the nonclinical tests demonstrates that the GlovaniI™ Blue Nitrile Gloves is as safe, as effective, and performs as well as or better than the legally marketed predicate device K200326.
§ 880.6250 Non-powdered patient examination glove.
(a)
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.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.