(101 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
The Powder Free Nitrile Examination Gloves (Blue) meets all the requirements of ASTM Specification D6319-10 - Standard Specification for Nitrile Examination Gloves for Medical Application.
The provided document is a 510(k) Pre-market Notification for Powder Free Nitrile Examination Gloves (Blue). This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, primarily focusing on product safety and effectiveness standards rather than complex AI algorithm performance.
Therefore, the requested information pertaining to AI algorithm studies (sample sizes for training/test sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance) is not applicable to this device.
The study described in this document is a non-clinical performance evaluation to demonstrate adherence to established medical device standards.
Here's the relevant information based on the document's content:
1. Table of Acceptance Criteria and Reported Device Performance
| CHARACTERISTICS | STANDARDS & ACCEPTANCE CRITERIA | DEVICE PERFORMANCE |
|---|---|---|
| Dimensions | ASTM D6319-10: Length: Size XS & S - min. 220mm; Size M & L - min. 230mm Width - min. 95 ± 10mm (Note: Comparison table implies specific widths for each size) | Meets ASTM D6319-10 Standard requirements Minimal Value for Length: 240mm Minimal Value for Width: 93mm (Note: This is a minimal value, implying other sizes met their specific width criteria. The comparison table shows the device claims to meet exact width ranges per size.) |
| Physical Properties | ASTM D6319-10: Tensile Strength: Before Aging: 14 MPa; After Aging: 14 MPa Ultimate Elongation: Before Aging: min. 500%; After Aging: min. 400% | Meets ASTM D6319-10 Standard requirements Tensile Strength: Before Aging: Minimal Value: 16.20 MPa; After Accelerated Aging: Minimal Value: 16.16 MPa Ultimate Elongation: Before Aging Minimal Value: 661%; After Aging Minimal Value: 630% |
| Thickness | ASTM D6319-10: Min. 0.05mm | Meets ASTM D6319-10 Standard requirements Palm – Minimal Value: 0.06mm Finger – Minimal Value: 0.13mm |
| Biocompatibility (Irritation) | ISO 10993-10: 2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Pass (Under the conditions of the study, the test article is a non-irritant) |
| Biocompatibility (Sensitization) | ISO 10993-10: 2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Pass (Under the conditions of the study, the test article is a non-sensitizer) |
| Freedom from Pinholes | 21 CFR 800.20; ASTM D5151-06 AQL 2.5 | Meets 21 CFR 800.20 and ASTM D5151-06 Standard requirements Passes AQL 2.5 |
| Powder Residual | ASTM D6124-06: ≤ 2 mg / glove | Meets ASTM D6124-06 Standard requirements Minimal Value: 0.68 mg |
2. Sample size used for the test set and the data provenance:
- The document does not specify the exact sample sizes used for each individual test (e.g., number of gloves tested for dimensions, tensile strength, pinholes, etc.).
- The data provenance is implied to be from tests conducted on the manufacturer's product, Nam Viet Glove Joint Stock Company in Vietnam. The description of tests being performed on "the test article" implies prospective testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For this type of medical device (examination gloves), "ground truth" is established by adherence to physical and chemical standards and test methods outlined by organizations like ASTM and ISO, not human expert consensus on interpretations. The results are objective measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As mentioned above, the tests involve objective measurements against predefined standards, not subjective interpretations requiring adjudication.
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. This device is a physical product (nitrile gloves), not an AI-powered diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is a physical product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" is defined by the objective specifications and quantifiable limits set by international standards (ASTM D6319-10, ISO 10993-10, ASTM D5151-06, ASTM D6124-06) and FDA regulations (21 CFR 800.20). Performance is measured directly against these specified values.
8. The sample size for the training set:
- Not Applicable. This applies to AI/machine learning models which are not relevant here.
9. How the ground truth for the training set was established:
- Not Applicable. This applies to AI/machine learning models which are not relevant here.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, arranged in a way that resembles a bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 7, 2016
Nam Viet Glove Joint Stock Company Ooi Loon Seng OA Manager Hamlet 7, Phuoc Binh Commune Long Thanh District Ho Chi Minh Dong Nai Province, VN 815300
Re: K162113
Trade/Device Name: Powder Free Nitrile Examination Gloves (Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: September 26, 2016 Received: October 3, 2016
Dear Ooi Loon Seng:
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. 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 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K162113 .
Device Name
Powder Free Nitrile Examination Gloves (Blue)
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
Type of Use (Select one or both, as applicable)
J Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
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510(k) SUMMARY 510(k) Number: K162113
1.0 Submitter :
Nam Viet Glove Joint Stock Company, Hamlet 7, Phuoc Binh Commune, Long Thanh District 815300, Dong Nai Province, Vietnam.
| Phone No. : | +84 08 3514 7788 |
|---|---|
| Fax No. : | +84 08 3840 8506 |
| Contact Person : | Ooi Loon Seng (Mdm) |
| Email : | lsooi@navigloves.com |
Date of Preparation : 01 November 2016
2.0 Name of the Device
Powder Free Nitrile Examination Gloves (Blue)
| Common Name | : | Nitrile Patient Exam Gloves |
|---|---|---|
| Classification Name | : | Patient Examination Gloves (21 CFR 880.6250 |
| Product Code | : | Nitrile — LZA |
3.0 Identification of The Legally Marketed Devices That Equivalency is Claimed:
Predicate Device :
RS Safe Blue Nitrile Medical Examination Gloves Powder Free (Non-Sterile) Company : Riverstone Resources Sdn. Bhd. 510(K) : K100603 Requlatory Class I Product Code : LZA
4.0 Description of the Device:
The Powder Free Nitrile Examination Gloves (Blue) meets all the requirements of ASTM Specification D6319-10 - Standard Specification for Nitrile Examination Gloves for Medical Application.
5.0 Intended Use of the Device
The Powder Free Nitrile Examination Glove (Blue) is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
6.0 Summary of the Technological Characteristics of the Device:
The Powder Free Nitrile Examination Gloves (Blue) are summarized with the following technological characteristics and is substantially equivalent to the predicate device with regard to
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Traditional 510(k) Premarket Notification Powder Free Nitrile Examination Gloves (Blue)
physical characteristics, design, product features, and intended use. Both gloves are made with nitrile latex and meets ASTM Specification D6319-10 - Standard Specification for Nitrile Examination Gloves for Medical Application or equivalent standards.
| CHARACTERISTICS | STANDARDS &ACCEPTANCE CRITERIA | DEVICE PERFORMANCE |
|---|---|---|
| Dimensions | ASTM D6319-10:Length:Size XS & S - min. 220mmSize M & L - min. 230mm | Meets ASTM D6319-10 StandardrequirementsMinimal Value for Length: 240mm |
| Width - min. 95 $\pm$ 10mm | Minimal Value for Width: 93mm | |
| Physical Properties | ASTM D6319-10:Tensile Strength:Before Aging: 14 MPaAfter Aging: 14 MPaUltimate Elongation:Before Aging: min. 500% | Meets ASTM D6319-10 StandardrequirementsTensile Strength:Before Aging: Minimal Value:16.20 MPaAfter Accelerated Aging:Minimal Value: 16.16 MPaUltimate Elongation:Before Aging Minimal Value: |
| After Aging: min. 400% | 661%After Aging Minimal Value: 630% | |
| Thickness | ASTM D6319-10:Min. 0.05mm | Meets ASTM D6319-10 StandardrequirementsPalm – Minimal Value: 0.06mmFinger – Minimal Value: 0.13mm |
| Biocompatibility | ISO 10993-10: 2010Biological evaluation ofmedical devices - Part 10:Tests for irritation and skinsensitization | Pass (Under the conditions of thestudy, the test article is a non-irritant) |
| Biocompatibility | ISO 10993-10: 2010Biological evaluation ofmedical devices - Part 10:Tests for irritation and skinsensitization | Pass (Under the conditions of thestudy, the test article is a non-sensitizer) |
| Freedom from Pinholes | 21 CFR 800.20; ASTMD5151-06AQL 2.5 | Meets 21 CFR 800.20 and ASTMD5151-06 Standard requirementsPasses AQL 2.5 |
| Powder Residual | ASTM D6124-06:$\leq$ 2 mg / glove | Meets ASTM D6124-06 StandardrequirementsMinimal Value: 0.68 mg |
7.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data
The performance test data of non-clinical tests that support a determination of substantial equivalence is the same as described in section 6.0 above and meet ASTM standards, and FDA requirements for water leak test on pinhole AQL.
8.0 Substantial Equivalent Based on Assessment of Clinical Performance Data
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Traditional 510(k) Premarket Notification Powder Free Nitrile Examination Gloves (Blue)
Not applicable - Clinical data is not needed for gloves or most devices cleared by the 510(k) process.
9.0 Substantial Equivalence Comparison
The Powder Free Nitrile Examination Gloves (Blue) is substantially equivalent to the predicate device with respect to intended use, product features and the technological characteristics. The substantial equivalence comparison is presented in the table below:
| Characteristic andparameters | Riverstone Resources Sdn.Bhd. K100603RS Safe Blue Nitrile MedicalExamination Gloves PowderFree (Non-Sterile)(Predicate) | Powder Free NitrileExamination Gloves (Blue)(Proposed) – K162113 | SubstantialEquivalence(SE) |
|---|---|---|---|
| Product Code | LZA | LZA | Same |
| Intended use | Intended for medical purposesthat is worn on the examiner'shands or fingers to preventcontamination between patientand examiner. | Intended for medical purposesthat is worn on the examiner'shands or fingers to preventcontamination between patientand examiner. | Same |
| Indications for UseStatement | A powder free patientexamination gloves is adisposable device intended formedical purposes that is wornon the examiner's hand orfinger to prevent contaminationbetween patient and examiner. | A patient examination glove is adisposable device intended formedical purposes that is worn onthe examiner's hand or finger toprevent contamination betweenpatient and examiner. | Same |
| Device Material | Nitrile Synthetic Latex | Nitrile Synthetic Latex | Same |
| Color | Blue | Blue | Same |
| Additives | No flavor additive | No flavor additive | Same |
| Instruction For Useon Labeling | Single Use Only | Single Use Only | Same |
| Construction | Ambidextrous | Ambidextrous | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Acceptance Criteria | ASTM D6319-10 | ASTM D6319-10 | Same |
Device Tolerances & Specifications :
| Meets ASTM D6319-10 | Meets ASTM D6319-10 | Same | |
|---|---|---|---|
| Dimensions | Overall Length:Size XS & S - min. 220mmSize M & L - min. 230mm | Overall Length:Size XS & S - min. 220mmSize M & L - min. 230mm | |
| Width (± 10mm)Size XS - 70mmSize S - 80mmSize M - 95mmSize L - 110mmSize XL - 120mm | Width (± 10mm)Size XS - 70mmSize S - 80mmSize M - 95mmSize L - 110mmSize XL - 120mm | ||
| Thickness at Finger - min.0.05mm | Thickness at Finger - min.0.05mm |
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Traditional 510(k) Premarket Notification Powder Free Nitrile Examination Gloves (Blue)
| Thickness at Palm - min.0.05mm | Thickness at Palm - min.0.05mm | ||
|---|---|---|---|
| Meets ASTM D6319-10 : | Meets ASTM D6319-10 : | ||
| Physical Properties | Before AgingTensile Strength – min. 14.0MPaUltimate Elongation - min.500% | Before AgingTensile Strength – min. 14.0 MPaUltimate Elongation - min. 500% | |
| After AgingTensile Strength - min. 14.0MPaUltimate Elongation - min.400% | After AgingTensile Strength – min. 14.0 MPaUltimate Elongation - min. 400% | ||
| Biocompatibility Testa. Irritation Testsb. SkinSensitizationTests | Under the conditions of thestudy, the test article is a non-irritant and non-sensitizer. | Under the conditions of thestudy, the test article is a non-irritant and non-sensitizer. | Same |
| Residual Powdertest | Meets ASTM D6124-06:<2 mg / glove | Meets ASTM D6124-06 | Same |
| Freedom from Holes | Meets ASTM D5151-06AQL 2.5 | Meets ASTM D5151-06AQL 2.5 | Same |
10.0 Conclusion
The Powder Free Nitrile Examination Gloves (Blue) meet all of the requirements of FDA-recognized consensus standards; ASTM D6319-10, ASTM D5151-06, ASTM D6124-06 and ISO 10993-10: 2010 and meet our labeling claims and pinhole acceptable quality level (AQL) as shown above.
There are no significant differences between the two products and are identical in terms of intended use, materials and performance.
The conclusion drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate device.
§ 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.