LATEX SURGICAL GLOVES, PRE-POWDERED by FITCO DIPPED PRODUCTS PVT. LTD

This Surgeon's Glove is a device made of natural rubber latex intended to be worn by operating room personnel to protect a surgical wound from contamination. Surface powder should be removed prior to undertaking operative procedures in order to minimise the risk of adverse tissue reaction. Contents sterile until package is opened or damaged.

Device Description

Class 1, 21 CFR 878.4460. Latex Surgical Gloves, 79 KGO and meets all requirements of ASTM standard D-3577-91.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: Latex Surgical Gloves (Pre-Powdered) by FITCO Dipped Products Pvt. Ltd.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Standard)	Reported Device Performance
ASTM D3577-91 requirements (Physical and Dimensional Testing)	Meets requirements (Inspection Level S-2, AQL 2.5)
FDA 1000 ml. Water Fill Test requirements	Meets requirements (Samplings of AQL 1.5, Inspection Level 1)
Primary Skin Irritation	No Primary Skin Irritation
Skin Sensitization (Allergic Contact Dermatitis)	No Sensitization Reactions
FDA's pinhole biocompatibility requirements	Meets requirements

2. Sample size used for the test set and the data provenance

Physical and Dimensional Testing (ASTM D3577-91): Inspection Level S-2, AQL 2.5. The exact sample size for this AQL (Acceptable Quality Limit) level is not explicitly stated but is determined by the lot size in accordance with the standard.
FDA 1000 ml. Water Fill Test: AQL 1.5, Inspection Level 1. Similar to above, the exact sample size is dependent on the lot size.
Primary skin irritation and Skin sensitization: The sample size for these biological tests is not explicitly stated in the provided text.
Data Provenance: The tests were conducted internally by FITCO Dipped Products Pvt. Ltd. (stated as a discussion of non-clinical tests performed by the submitter). The country of origin is India. The nature of the tests (physical, dimensional, water fill, biological) implies these were prospective tests conducted on manufactured product.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The ground truth for these types of products (surgical gloves) is established through adherence to standardized test methods (ASTM, FDA water fill test) and biological compatibility tests, rather than expert consensus on specific cases. The "experts" would be the technicians conducting the tests and interpreting the results according to the established standards.

4. Adjudication method for the test set

Not applicable. This type of adjudication (e.g., 2+1, 3+1) is typically used in clinical studies or image-based diagnostic evaluations where individual expert opinions need to be reconciled to establish a ground truth. For product performance standards, passing or failing the defined criteria in the standard is generally clear-cut.

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 medical device (surgical glove), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance are irrelevant to its evaluation.

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

Not applicable, as this is not an algorithm or AI-based device. The "standalone performance" is the performance of the glove itself as demonstrated by the non-clinical tests.

7. The type of ground truth used

The ground truth used is based on:

Established Industry Standards: ASTM D3577-91 for physical and dimensional characteristics.
Regulatory Test Methods: FDA 1000 ml. Water Fill Test for barrier integrity (pinholes).
Biological Testing: Primary skin irritation and skin sensitization tests (implicitly following recognized protocols for such assessments).

8. The sample size for the training set

Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

Summary

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ATTACHMENT - I

K993450

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 identificationSummary prepared on	: Joseph. J. E. PereiraFITCO Dipped Products Pvt. Ltd.14 A, Cochin Export Processing Zone,.Cochin - 682 030, Kerala, INDIA28th September, 1999
2.	Name of the Device	: Latex Surgical Gloves
3.	Predicate Device Information	: Class 1 Latex Surgical Gloves which meetsthe requirements of ASTM D3577-91.The equivalent device identified in the market is theLatex Surgical Gloves marketed by Kanam LatexIndustries Pvt. Ltd., INDIA [510K NO. K904972]under brand name SURGICARE
4.	Device Description	: Classified by FDA's General and Plastic SurgeryDevice Panel asClass 1, 21 CFR 878.4460. Latex Surgical Gloves,79 KGO and meets all requirements of ASTMstandard D-3577-91.
5.	Intended Use	: This device is intended to be used as a single usedisposable Sterile Surgical Gloves
6.	Comparison to Predicate Devices	: The Latex Surgical Gloves manufacturedby FITCO Dipped Products Pvt. Ltd. is substantiallyequivalent in safety and effectiveness to the SterileLatex Surgical Gloves marketed by Kanam LatexIndustries Pvt. Ltd. India [510K NO. K904972]

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K993450

Discussion of Non-clinical Tests performed for determination of substantial equivalence are as 7. follows:
The standards used for Latex Surgical Gloves production are based on ASTM-D-3577-91. All tests meet requirements of Physical and Dimensional 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, claim and we do not claim our gloves as hypo allergenic on our labels.

FITCO Dipped Products Pvt. Ltd., operates in compliance with FDA's GMPs.

1. Discussion of Clinical Tests Performed:
  Not applicable - there is no hypoallergenic claim.
1. Conclusions:
  The Latex Surgical Gloves manufactured by FITCO Dipped Products Private Limited. conform fully ASTM-D- 3577-91 standards as well as applicable 21 CFR references, and meets FDA's pinhole bio-compatibility requirements and labelling claims as shown by data in our restrictions. 510(k).There are no safetylefficacy 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 our predicate device.

For Fitco Dipped Products Ps

J J E Pereira
Director.

Signature Date : 28th September, 1999

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus-like design with three wavy lines, representing health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 9 1999

Mr. Joseph J.E. Pereira Official Correspondent for Fitco Dipped Products Pvt. Ltd. Plot No. 14 - A Cochin Export Processing Zone Kakkanad, Cochin - 682 030 Kerala, India

Re : K993450 Latex Surgical Gloves , Pre-Powdered Trade Name: Requlatory Class: I Product Code: KGO September 28, 1999 Dated: Received: October 12, 1999

Dear Mr. Pereira:

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 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 895. A 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 the Federal Register. Please note: this response to your premarket notification submission does not affect any

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Page 2 - Mr. Pereira

obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to beqin 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,

Harold W. Sharpn

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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Attachment III

Indication for use statement

5 I0 ( K ) Number ( if known ) 993450 : Not known

Device Name

Indications for use

Latex Surgical Gloves , PRE - POWDERED :

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

Surface powder should be removed prior to undertaking operative procedures in order to minimise the risk of adverse tissue reaction.

Contents sterile until package is opened or damaged.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

ﺎ Over-The-Counter-Use (Optional Format 1-2-96)

Aamy Summy for Chutein

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

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).