A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Device Description

Sterile Powdered Latex Surgical Gloves with Protein Labeling Claim ( 200 Micrograms or Less )

AI/ML Overview

This document is a letter from the FDA regarding a 510(k) premarket notification for "Sterile Powdered Latex Surgical Gloves with Protein Labeling Claim (200 Micrograms or Less)."

It is important to understand that a 510(k) notification is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through a study with the detail you've requested for AI/software devices.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment will not be found in this document. This document focuses on the regulatory clearance process for a physical medical device (gloves), not a software or AI-driven diagnostic tool.

Information that CANNOT be Extracted from the Provided Document:

A table of acceptance criteria and the reported device performance: This document does not detail specific performance metrics beyond the protein labeling claim.
Sample size used for the test set and the data provenance: Not applicable to this type of device clearance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical device, not an algorithm.
The type of ground truth used: Not applicable in the context of AI/software ground truth.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Information that CAN be Extracted (and interpreted in the context of a 510(k) physical device):

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

While not structured as a typical "acceptance criteria" table for an AI study, the core claim being reviewed for this device is the "Protein Labeling Claim (200 micrograms or less)." The FDA's issuance of the 510(k) implies that the manufacturer provided sufficient data (likely through testing following recognized standards for surgical gloves) to substantiate this claim and demonstrate substantial equivalence to a predicate device.

Implied "Acceptance Criteria" Category	Device Performance as per FDA Clearance
Protein Content Claim	"200 Micrograms or Less"
Device Type	Sterile Powdered Latex Surgical Gloves
Intended Use	Worn by operating room personnel to protect a surgical wound from contamination.
Premarket Review Outcome	Substantially Equivalent to legally marketed predicate devices.

Summary of "Study" (as implied by a 510(k) for this device):

The "study" for a 510(k) for a physical device like surgical gloves typically involves:

Material Characterization: Demonstrating the material properties of the gloves meet relevant standards (e.g., ASTM, ISO) for strength, elasticity, freedom from holes, etc.
Sterility Testing: Validating the sterilization process to ensure the gloves are sterile.
Biocompatibility Testing: Ensuring the materials are safe for skin contact, often through tests like cytotoxicity, sensitization, and irritation.
Protein Content Testing: Specific analytical testing methods (e.g., modified Lowry method, ELISA) to quantify the amount of extractable protein to substantiate the "200 micrograms or less" claim.
Shelf-life Testing: Stability studies to ensure the device maintains its properties over its declared shelf life.

The 510(k) process primarily relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often by showing it meets recognized consensus standards (like ASTM D3577 for surgical gloves) and has the same technological characteristics and intended use, or that any differences do not raise new questions of safety or effectiveness. The document states a "protein labeling claim" of 200 micrograms or less, which would have been substantiated by specific testing.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 6 2001

Mr. Clinton A. Teck Leong Managing Director SSN Glove (M) Sdn Bhd No. 1, Jalan 203, Off Jalan Tandang Petaling, Jala Selangor, MALAYSIA

Re: K012896

Trade/Device Name: Sterile Powdered Latex Surgical Gloves with Protein Labeling Claim ( 200 Micrograms or Less ) Regulation Number: 878.4460 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: KGO Dated: August 23, 2001 Received: August 28, 2001

Dear Mr. Leong:

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 mendments, 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 approvisions 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.

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Page 2 - Mr. Leong

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 moan that I DX mas mace a aves and regulations administered by other Federal agencies. or the Act of ally I outs an the Act's requirements, including, but not limited to: registration r ou must comply with and 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 OF RT rat 007), assimm (QS) regulation (21 CFR Part 820); and if requirents as set form in als quadistion 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 1 mis letter will and w you to organized a finding of substantial equivalence of your device to 310(k) promative noticate 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 If you desire openite and Rart 809.10 for in vitro diagnostic devices), please contact the and additionally 21 Cr (301) 594-4618. Additionally, for questions on the promotion and Office of Confightance are, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket Alloo, predo 1000 R Part 807.97). Other general information on your responsibilities under notification (11 Crice it from the Division of Small Manufacturers, International and the Net may be obtained 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,

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

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NOV 1 6 2001

INDICATIONS FOR USE

Applicant	:	SSN Gloves (M) Sdn Bhd
510(k) Number	:	K012896
Device Name	:	Sterile Powdered Latex Surgical Gloves with ProteinLabeling Claim<200 micrograms or less )
Indication For Use	:	A surgeon's glove is a device made of natural or syntheticrubber intended to be worn by operating room personnelto protect a surgical wound from contamination.

Section 3 - Page 1 of 1

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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).