COLOURED POWDWR-FREE SURGICAL GLOVES by KENWELL INTERNATIONAL LTD.

This device is intended to be used as a single use disposable sterile surgical glove.
This Surgeon's Glove is a device made of naturel rubber latex intended to be worn by operating room personnel to protect a surgical wound from contamination.

Device Description

Classified by FDA's General and Plastic Surgery Device Panel as Class 1, 21 CFR 878.4460, Surgical Powder-free Latex Gloves, 79KGO and meets all requirements of ASTM standard D-3577-91.

AI/ML Overview

The provided documents describe the acceptance criteria and a study to demonstrate the substantial equivalence of Kemwell International Ltd.'s "Coloured Powder-free Latex Surgical Gloves" (later specified as "Green Powder-Free Latex Surgical Gloves") to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (ASTM D 3577-91)	Reported Device Performance
Physical and Dimensional Testing	Meets ASTM D 3577-91 requirements	Met
Pinhole (Water Fill Test)	AQL 1.5 (Inspection Level 1)	Met
Primary Skin Irritation	No primary skin irritation reactions	No primary skin irritation reactions
Skin Sensitization (Contact Dermatitis)	No sensitization reactions	No sensitization reactions

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

Physical and Dimensional Testing: Inspection Level S-2, AQL 2.5. The exact number of gloves sampled is not explicitly stated but is determined by the AQL (Acceptance Quality Limit) and inspection level per ASTM standards.
Pinhole (Water Fill Test): AQL 1.5, Inspection Level 1. The exact number of gloves sampled is not explicitly stated but is determined by the AQL and inspection level per FDA standards.
Primary Skin Irritation and Skin Sensitization Testing: The sample size for these biocompatibility tests (e.g., number of test subjects or animals) is not specified in the provided text.
Data Provenance: The device manufacturer, Kemwell International Ltd., is based in Bangalore, India. The document does not explicitly state the country of origin for the test data, but it is implied to be associated with tests conducted by or for Kemwell. These seem to be prospective tests performed specifically for this 510(k) submission.

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

This type of information is not applicable to this submission. The tests performed are objective, laboratory-based evaluations against established industry standards (ASTM D 3577-91) and regulatory requirements (FDA Water Fill Test, biocompatibility). Expert consensus for "ground truth" as typically seen in AI or diagnostic device studies (e.g., radiologists interpreting images) is not a component of glove testing.

4. Adjudication Method for the Test Set

Not applicable. As the tests are objective measurements against defined acceptance limits, there is no need for an adjudication method by human 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 (surgical gloves). This is a study demonstrating compliance with product standards rather than a comparative effectiveness study involving human readers or interpretation of results.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This submission is for a physical medical device (surgical gloves), not an algorithm or AI software. Therefore, the concept of "standalone performance" for an algorithm is not relevant.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the objective performance specifications defined by:

ASTM D 3577-91 standards for physical and dimensional properties.
FDA 1000 ml. Water Fill Test requirements for pinhole integrity.
Biocompatibility testing standards for primary skin irritation and sensitization.

These standards and requirements serve as the benchmarks against which the device's performance is measured.

8. The Sample Size for the Training Set

Not applicable. This submission is for a physical medical device (surgical gloves). There is no "training set" in the context of machine learning, as this device does not involve an algorithm that learns from data.

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

Not applicable. As there is no training set, there is no ground truth established for it.

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 - 8 1998

K980412

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	January 19, 1998
2. Name of the Device	Coloured Powder-free Latex SurgicalGloves.
3. Predicate Device Information	Class I powder-free Latex Surgical Gloveswhich meets the requirements of ASTM D3577-91. The equivalent device identified inthe market is SAFESKIN-SUPRA ofSafeskin Corporation, USA(This product isof natural colour).
4. Device Description	Classified by FDA's General and PlasticSurgery Device Panel as Class 1, 21 CFR878.4460, Surgical Powder-free LatexGloves, 79KGO and meets all requirementsof ASTM standard D-3577-91.
5. Intended Use	This device is intended to be used as a singleuse disposable sterile surgical glove.
6. Comparison to Predicate Devices	Kemwell International Ltd. Powder-freeLatex Surgical Gloves is substantiallyequivalent in safety and effectiveness to thegloves sold by Safeskin Corporation USA,the brand name SAFESKIN-SUPRA.

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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 KIPLIN FAX : 91-80-8391450/8396345

1. Discussion of Non-clinical Tests performed for determination of substantial equivalence are as follows:
  The standards used for Coloured Powder-free Latex Surgical Gloves production are based on ASTM-D-3577-91. All test 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.

Discussion of Clinical Tests Performed:

Not applicable - there is no hypoallergenic claim.

1. Conclusions:
  Kemwell International Ltd. Coloured Powder-free Latex Surgeon's Glove conform fully to ASTM-D-3577-91 standards as well as applicable 21 CFR references, and meets pinhole FDA requirements, biocompatibility requirements and labelling 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.,

SIGNATURE:

C. ALVA, General Manager (Technical)

DATE:19-1-1998

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 8 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 : K980412 Green Powder-Free Latex Surgical Gloves Trade Name: Regulatory Class: I Product Code: KGo Dated: January 29, 1998 Received: February 3, 1998

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, good manufacturing practice, labeling, and prohibitions aqainst 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 895. ਜੋ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your 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 regulations.

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 requlation (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 general 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,

Patricia Cucciniello

Timothy A. Ulatowski 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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Page	1 of 1
Attachment III

510(k) Number (if known):	K980412
Device Name:	Green Coloured Powder-free Latex Gloves Surgeon's

Indications For Use:

This Surgeon's Glove is a device made of naturel rubber latex intended to be worn by operating room personnel to protect a surgical wound from contamination.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

and General Hospital Devices
510(k) Number	K980412

Prescription Use (Per 21 CFR 801.109)	CR	Over-The-Counter Use	X
---------------------------------------	----	----------------------	---

(Optional Format 1-2-96)

Regulation Number and Section

§ 878.4460 Non-powdered surgeon's glove.

(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).