This device is intended to be used as a single use disposable sterile examination glove.
This Examination Glove is a device made of natural rubber latex intended to be worn by medical personnel to prevent cross contamination between them and the patient.

Device Description

Classified by FDA's General and Plastic Surgery Device Panel as Class 1, 21 CFR 878.4460, Examination Powder-free Latex Gloves, 80 LYY and meets all requirements of ASTM standard D-3578-95.

AI/ML Overview

This submission describes the Kemwell Sterile Powder-Free Latex Examination Gloves. As a medical device, its performance criteria and the studies conducted are detailed to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard)	Reported Device Performance
ASTM-D-3578-95 (Physical and Dimensions Testing, Inspection Level S-2, AQL 2.5)	All tests meet requirements
FDA 1000 ml. Water Fill Test (AQL 1.5, Inspection Level 1)	Meets requirements
Primary skin Irritation	No primary skin irritation
Skin Sensitization (allergic contact dermatitis)	No sensitization reactions
Pinhole FDA requirements	Meets requirements
Biocompatibility requirements	Meets requirements
Labeling claims	Meets requirements

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the exact sample sizes for each specific test (e.g., physical dimensions, water-fill test, skin irritation, sensitization). However, it mentions specific AQL (Acceptable Quality Level) values for inspection levels:

Physical and Dimensions Testing: Inspection Level S-2, AQL 2.5
FDA 1000 ml. Water Fill Test: AQL 1.5, Inspection Level 1

These AQL values imply a statistically relevant sampling plan was used according to the specified ASTM and FDA standards for quality control testing.

The provenance of the data is retrospective, as the tests were performed on finished products to demonstrate compliance with established standards. The data originates from Kemwell International Ltd. in Bangalore, India, where the gloves are manufactured.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This type of submission for examination gloves does not typically involve human experts establishing a "ground truth" for the test set in the way a diagnostic AI device would. The "ground truth" for these performance tests is based on objective, quantifiable measurements against established engineering and safety standards (e.g., glove dimensions, force at break, waterproof integrity). Therefore, there is no mention of a number of experts or their qualifications for this purpose.

4. Adjudication Method for the Test Set

Not applicable. As described above, the tests are based on objective measurements against established standards, not subjective assessments requiring adjudication by multiple experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study is not relevant for this type of device (sterile powder-free latex examination gloves). Such studies are typically conducted for diagnostic or interpretive devices where human readers (e.g., radiologists, pathologists) interpret images or data, and their performance is compared with and without AI assistance. This device is a physical barrier intended for protection.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

No. This concept is not applicable to a physical product like examination gloves. "Standalone performance" refers to the accuracy of an AI algorithm in performing a task without human intervention, which is not relevant to the function of a glove.

7. Type of Ground Truth Used

The ground truth used for these tests is based on objective, quantifiable measurements against predefined performance and safety criteria specified in:

ASTM-D-3578-95 (Standard Specification for Rubber Examination Gloves)
FDA 1000 ml. Water Fill Test procedures
Biocompatibility standards related to primary skin irritation and sensitization.

Essentially, the "ground truth" is compliance with these universally accepted standards for product quality and safety.

8. Sample Size for the Training Set

Not applicable. This device is a physical product, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The manufacturing process is guided by established engineering principles and quality control, not by training data for an algorithm.

9. How the Ground Truth for the Training Set was Established

Not applicable. As stated above, there is no training set for this device.

Summary

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KEMWELL

Kemwell International Ltd. 3-B, II PHASE, PEENYA BANGALORE 560 058, INDIA PH : 91-80-8395701/8392354 TLX : 845-5078 KIPL IN FAX : 91-80-8391450/8396345

APR - 3 1998

K98 v 80 3

Attachment I

510(k) SUMMARY

This summary of 510 (k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510 (k) number is :

1. Submitter's identification	C ALVAKemwell International Ltd.3-B, Peenya, II PhaseBangalore 560 058, INDIA.
Date Summary prepared	February 9, 1998
2. Name of the Device	Sterile Powder-Free Latex Examination Gloves
3. Predicate Device Information	Class I powder-free Latex Examination Gloves which meets the requirements of ASTM D 3578-95. The equivalent device identified in the market is the powder-free examination gloves marketed by SAFESKIN Corporation, USA.
4. Device Description	Classified by FDA's General and Plastic Surgery Device Panel as Class 1, 21 CFR 878.4460, Examination Powder-free Latex Gloves, 80 LYY and meets all requirements of ASTM standard D-3578-95.
5. Intended Use	This device is intended to be used as a single use disposable sterile examination glove.
6. Comparison to Predicate Devices	Kemwell International Ltd. Powder-free Latex Examination Gloves is substantially equivalent in safety and effectiveness to the powder-free examination gloves sold by Safeskin Corporation USA.

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KEMWELL

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1. Discussion of Non-clinical Tests performed for determination of substantial equivalence are as follows:
  The standards used for Sterile Powder-Free Latex Examination Gloves production are based on ASTM-D-3578-95. All tests meet requirements of Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQL 2.5.

The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 1.5, Inspection Level 1 meeting these requirements. Primary skin Irritation and Skin sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritation or sensitization reactions.

There are no special labelling claims and we do not claim our gloves as hypoallergenic on our labels.

Kemwell International Ltd., operates in compliance with FDA's GMPs.

1. Discussion of Clinical Tests Performed:
  Not applicable - there is no hypoallergenic claim.
1. Conclusions:
  Kemwell International Ltd. Sterile Powder-Free Latex Examination Glove conform fully o ASTM-D-3578-95 standards as well as applicable 21 CFR references, and meets pinhole FDA requirements, biocompatibility requirements and labeling claims as shown by data in our 510(k). There are no safety/efficacy issues or new claims from the 'Substantial equivalence" products cited

Based on the non-clinical tests our product has demonstrated to be as safe as effective as our predicate device.

For KEMWELL INTERNATIONAL LTD. C.ALVA GENERAL MANAGER (TECH.)

Date: February 9, 1998

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 3 1998

Kemwell International, Ltd. C/O Ms. Susan D. Goldstein-Falk Official Correspondent for Kemwell International Ltd. MDI Consultants 55 Northern Boulevard, Suite 410 Great Neck, New York 11021

Re : K980803 Powder-Free Sterile Latex Examination Gloves Trade Name: Requlatory Class: I Product Code: LYY February 26, 1998 Dated: March 2, 1998 Received:

Dear Ms. Goldstein-Falk:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 89500 A-1000 substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Reqister. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Ms. Goldstein-Falk

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K980803

Sterile Powder-Free Latex Examination Gloves

Device Name:

Indications For Usc:

This Examination Glove is a device made of natural rubber latex intended to be worn by medical personnel to prevent cross contamination between them and the patient.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Clive S. Lin

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use X

・・

(Optional Formal 1-2-96)

Regulation Number and Section

§ 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.