POWDERFREE LATEX SURGEON'S GLOVES by KANAM LATEX INDUSTRIES PVT. LTD.

A Powder - free surgeon's glove is a disposable device made of natural latex that may bear a trace amount of glove powder but not more than 2 milligrams per glove may bour a trace anounces on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contamination.

Device Description

Powder Free Latex Surgeon's Gloves with Protein Contact Labeling Claim (50 Micrograms or Less)

AI/ML Overview

This document is a 510(k) premarket notification approval letter for Powder Free Latex Surgeon's Gloves with Protein Contact Labeling Claim (50 Micrograms or Less), manufactured by Kanam Latex Industries PVT. Limited.

This is not a study report for a device performance, but rather an FDA approval for marketing the product based on its substantial equivalence to a legally marketed predicate device. Therefore, the detailed information requested in the prompt regarding acceptance criteria, study design, sample sizes, ground truth, and expert involvement is not present in the provided text.

The document only states that the device is "substantially equivalent" to predicate devices for its stated indications for use.

Here's what can be extracted and what cannot be from the provided text:

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

Not available. The document does not provide a table of acceptance criteria or specific performance metrics for the Kanam Latex Surgeon's Gloves. It only states that the device is "substantially equivalent" to legally marketed predicate devices. The "Protein Contact Labeling Claim (50 Micrograms or Less)" implies a specific characteristic, but no performance data against this claim is provided.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not available. The document does not mention any sample sizes for test sets or data provenance. The approval is based on substantial equivalence, not a detailed performance study presented in this letter.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not available. This information is irrelevant to a 510(k) substantial equivalence determination. No ground truth establishment for a test set is discussed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not available. No test set or adjudication method is described in this regulatory letter.

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 / Not available. This device is a surgical glove, not an AI-powered diagnostic tool. Therefore, MRMC studies or AI assistance are not relevant.

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

Not applicable / Not available. This device is a physical product (surgical gloves), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not available. The concept of "ground truth" as typically applied to performance studies of diagnostic or AI devices is not relevant to this 510(k) submission for surgical gloves. The basis for approval is substantial equivalence to a predicate device.

8. The sample size for the training set:

Not applicable / Not available. As this is a physical medical device (surgical gloves) and not a machine learning algorithm, there is no "training set."

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

Not applicable / Not available. As there is no training set, this information is not applicable.

Summary from the document:

Device Name: Powder Free Latex Surgeon's Gloves with Protein Contact Labeling Claim (50 Micrograms or Less)
Manufacturer: Kanam Latex Industries PVT. Limited (India)
Regulatory Class: I
Product Code: KGO
Indication for Use: "A Powder - free surgeon's glove is a disposable device made of natural latex that may bear a trace amount of glove powder but not more than 2 milligrams per glove may bour a trace anounces on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contamination."
Approval Basis: Substantial equivalence to legally marketed predicate devices.
Approval Date: February 6, 2002

To obtain the detailed study information as requested, one would need to refer to the actual 510(k) summary submitted by Kanam Latex Industries PVT. Limited, which often contains details of biocompatibility testing, protein content testing, and other performance studies demonstrating substantial equivalence. This letter is merely the FDA's decision based on that submission.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 6 2002

Mr. Ravi Abraham Managing Director Kanam Latex Industries PVT. Limited Ooppoottil Buildings K.K. Road, P.O. Box 28, Kottayam, Kerala-686 001 INDIA

Re: K013914

Trade/Device Name: Powder Free Latex Surgeon's Gloves with Protein Contact Labeling Claim (50 Micrograms or Less) Regulation Number: 878.4460 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: KGO Dated: November 12, 2001 Received: November 27, 2001

Dear Mr. Abraham:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

{1}------------------------------------------------

Page 2 - Mr. Abraham

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

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

Enclosure

{2}------------------------------------------------

KANAM LATEX INDUSTRIES PRIVATE LIMITED

ISO 9002 Certified Company

Reg. & Sales Office : Ooppoottil Buildings, P.O. Box No.28, K.K. Road, Kottayam - 686001. Kerala Ph. : 300343, Telex : 0888 - 281 Optl in. Fax No.91 - 481 - 563614 e-mail - kanam @ md2.vsnl.net.in website - www. kanamlatex.com

Factory : West Peruvitai, Pallavilai, Nagercoil - 629 003. Tamil Nadu, S. India. TNGST No. 6160681. CST : 461477 Dt.6.1.1987

Image /page/2/Picture/5 description: The image is a black and white logo for Surgicare. The logo features a pair of hands wearing surgical gloves. The hands are positioned in a way that suggests they are performing a delicate procedure or handling surgical instruments.

INDICATIONS FOR USE

APPLICANT

KANAM LATEX INDUSTRIES PVT LTD

510 (K) NO

DEVICE NAME

DERFREE LATEX SURGEON'S GLOVES WITH EIN CONTENT LABELING CLAIM (50 MICROGRAMS

INDICATIONS FOR USE.

(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

Over-The-Counter Use √

(Optional Format 1-2-96)

Bissell for Clin

vision Sign-Off) ാസ്ട്രോസ് വിവാഹം and General Hospital Devices * ( 18) 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).