A powdered 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.

A powder-free 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

The Surgical Glove is made of all natural rubber, sterile, and powdered with USP absorbable dusting powder and contains less than 50 micrograms or less of protein content.

AI/ML Overview

The provided text describes a 510(k) summary for surgical gloves, which are medical devices and not typically subject to the same kind of "AI model performance" studies as software algorithms. The request asks for details that are common for AI/ML device evaluations (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance), but these are not relevant for the described device (surgical gloves).

Therefore, I will extract the available acceptance criteria and device performance based on the provided document. I will also explicitly state that the other requested information (sample size for test set, experts for ground truth, adjudication, MRMC, standalone performance, training set details) is not applicable or not provided for this type of device submission.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Characteristics	Standards (Acceptance Criteria)	Device Performance
Dimensions	ASTM D 3577-09e1	Meets
Physical Properties	ASTM D 3577-09e1	Meets
Freedom from pinholes	ASTM D 3577-09e1	Meets
Powder Residual	ASTM D 6124-06	Meets
Protein Level	ASTM D 5712-10	Meets
Biocompatibility: Primary Skin Irritation in Rabbits	(Implied standard for "Passes")	Passes (Not a primary skin irritant)
Biocompatibility: Dermal Sensitization	(Implied standard for "Passes")	Passes (Not a primary skin irritant)
Sterilization Validation	ISO 11137-2:2006	Meets

Additionally, the conclusion states the device meets "FDA requirements for water leak test on pinhole AQL" and "glove performance standards."

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

This information is not applicable or not provided for this type of medical device (surgical gloves). Device performance is typically evaluated against established ASTM and ISO standards, which define testing methodologies and sample sizes within those standard documents, rather than through independent "test sets" in the context of an AI/ML algorithm. The data provenance would refer to the materials and manufacturing process.

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

This information is not applicable or not provided. The "ground truth" for surgical glove performance is established by the specified ASTM and ISO standards and their associated test methods, not by expert consensus on data interpretation.

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

This information is not applicable or not provided. Adjudication methods are relevant for subjective interpretations, often in image analysis or clinical diagnosis. Surgical glove testing involves objective physical, chemical, and biological tests.

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

This information is not applicable or not provided. MRMC studies are used for evaluating the impact of diagnostic aids (often AI) on human reader performance. This submission is for a physical medical device (surgical gloves).

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

This information is not applicable or not provided. This concept applies to standalone software algorithms or AI models, not to physical devices like surgical gloves.

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

The "ground truth" for this device is based on objective measurements defined by international and national standards (ASTM D 3577-09e1, ASTM D 6124-06, ASTM D 5712-10, ISO 11137-2:2006) and established biocompatibility tests (Primary Skin Irritation in Rabbits, Dermal Sensitization). For instance, freedom from pinholes is measured by a water leak test, and protein level via a standard chemical assay.

8. The sample size for the training set

This information is not applicable or not provided. "Training set" refers to data used to train an AI/ML model, which is not relevant for surgical gloves.

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

This information is not applicable or not provided.

Summary

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K113233

MAR 2 9 2012

510(k) SUMMARY

1.0 Submitter

Name
Street Address
Phone No.
Fax No.

Shen Wei (USA) Inc. 33278 Central Ave., Suite 102 Union City, CA. 94587 (510)429-8692 (510)487-5347

Date of Summary Prepared: 12/29/2010

Name and Location of Actual Manufacturers:

Name	Zhenjiang Kangda Emulsion Co., Ltd.
Address	Lianhe Town, Yangzhong City, Zhenjiang
Country	China
Phone No.	(511)551-1390
Fax No.	(511)832-2861

Zhengjiagang Dayu Rubber Products CO., LTD. Xizhang Town, Zhangjiagang City, Jiangsu China 520-945-0023 Phone No. Fax No. 520-845-0311

2.0 Contact Person:

Name:

Address Country

Name:	Mr. Albert T Li
Phone No.	(510)429-8692
Fax No.	(510)487-5347

3.0 Device Identification:

Glove Proprietary or Trade Name: Powdered Latex Surgical Gloves Sterile; Powder Free Latex Surgical Gloves, Sterile with Protein Content Labeling Claim (50 micrograms or less)

Common Name: Surgical Gloves

Classification Name: Surgeon's gloves - 21 CFR 878.4460

Predicate Device: K063757 Motex Powder-Free Surgical Gloves and Powdered Latex surgical Gloves

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4.0 Identification of the Legally Marketed Device or Predicate Devices:

Class I Powder Free, Powdered natural rubber latex Surgeon's gloves, 79KGO, this surgical glove described in this 510(k) is substantially equivalent to K063757.

5.0 Description of the Device:

The Surgical Glove is made of all natural rubber, sterife, and powdered with USP absorbable dusting powder and contains less than 50 micrograms or less of protein content.

6.0 Intended Use of Device:

A powdered 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.

A powder-free 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.

7.0 Summary of Technological Characteristics for Modified Device:

The Powdered Latex Surgical Gloves Sterile: Powder Free Latex Surgical Gloves. Sterile with Protein Content Labeling Claim (50 micrograms or less) are summarized with the following technological characteristics compared to ASTM or equivalent standards.

Characteristics	Standards	Device Performance
Dimensions	ASTM D 3577-09e1	Meets
Physical Properties	ASTM D 3577-09e1	Meets
Freedom from pinholes	ASTM D 3577-09e1	Meets
Powder Residual	ASTM D 6124-06	Meets
Protein Level	ASTM D 5712-10	Meets
Biocompatibility	Primary Skin Irritationin Rabbits	Passes(Not a primary skinirritant)
	Dermal Sensitization	Passes(Not a primary skinirritant)
Sterilization Validation	ISO 11137-2:2006	Meets

8.0 Sterility:

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Name of Sterilization Company: Yangzhou Irradiation Processing Center Address: No. 568, vangziliang North Road, Yangzhou, China Phone Number: 086-514-87300601

The Powdered Latex Surgical Gloves Sterile; Powder Free Latex Surgical Gloves, Sterile with Protein Content Labeling Claim (50 micrograms or less) are sterilized using 25 Kilograys of Gamma Radiation and have a Sterility Assurance Level (SAL) of 10-6.

The sterilization cycle has been validated according to ISO 11137-2:2006 method.

9.0 Packaging and Labeling:

The Powdered Latex Surgical Gloves Sterile; Powder Free Latex Surgical Gloves, Sterile with Protein Content Labeling Claim (50 micrograms or less) are packaged in sterilization pouches that are paper bags or paper/plastic bags and sealed and packaged into an outer carton. The entire carton is then sterilized by Gamma radiation specified in section 9.0. View Attachment 3 for labeling details.

10.0 Conclusion:

The Powdered Latex Surgical Gloves Sterile; Powder Free Latex Surgical Gloves, Sterile with Protein Content Labeling Claim (50 micrograms or less) will perform according to the glove performance standards reference in section 7 above and meet ASTM standards, and FDA requirements for water leak test on pinhole AQL. Consequently, this device is substantially equivalent to currently marketed devices such as K063757.

ﺩﻣﺎ

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes extending from its back, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MAR 2 9 2012

Mr. Albert Li Project Manager Shen Wei (USA) Inc. 33278 Central Ave. Suite 102 Union City, California 94587

Re: K113233

Trade/Device Name: Powdered Latex Surgical Gloves Sterile; Powder Free Latex Surgical Gloves, Sterile with Protein Content Labeling Claim (50 micrograms or less)

Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: March 13, 2012 Received: March 15, 2012

Dear Mr. Li:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony D. Watson, B.S., M.S., M.B.A. Director

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

Enclosure

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Attachment Two

INDICATION FOR USE

Applicant: Shen Wei (USA) Inc.

Device Name: Powdered Latex Surgical Gloves Sterile; Powder Free Latex Surgical Gloves, Sterile with Protein Content Labeling Claim (50 micrograms or less)
Indication For Use:

A powdered 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.

A powder-free 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.

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Elizabeth F. Claiborne Williams

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K 113233

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).