Motex Powder-Free Surgical Gloves are sterile disposable devices made of natural rubber latex (that may bear a trace amount of glove powder) and is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

Motex Powdered Latex Surgical Gloves are sterile disposable devices made of natural rubber latex that bears powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

Device Description

Motex Powder-Free Surgical Gloves are sterile disposable devices made of natural rubber latex (that may bear a trace amount of glove powder).

Motex Powdered Latex Surgical Gloves are sterile disposable devices made of natural rubber latex that bears powder to facilitate donning.

The characteristics are summarized below compared to ASTM and ISO standards to the predicate device:
Characteristic: Dimensions, Standard: meets ASTM D 3577-06,
Characteristic: Physical Properties, Standard: meets ASTM D 3577-06,
Characteristic: Freedom from Holes, Standard: meets ASTM D 3577-06,
Characteristic: Biocompatibility, Standard: meets ISO10993-5/-10
Characteristic: Sterilization Validation, Standard: meets ISO11137

AI/ML Overview

The acceptance criteria and device performance are described below:

1. Table of Acceptance Criteria and Reported Device Performance:

Characteristic	Acceptance Criteria (Standard)	Reported Device Performance
Dimensions	ASTM D 3577-06	Meets ASTM D 3577-06
Physical Properties	ASTM D 3577-06	Meets ASTM D 3577-06
Freedom from Holes	ASTM D 3577-06	Meets ASTM D 3577-06
Biocompatibility	ISO10993-5/-10	Meets ISO10993-5/-10
Sterilization Validation	ISO11137	Meets ISO11137
Powder content (Powder-Free Gloves)	No more than 2mg powder	No more than 2mg powder
Extractable protein (Powder-Free Gloves)	No more than 50ug/dm2	No more than 50ug/dm2
Powder content (Powdered Gloves)	No more than 120mg powder	No more than 120mg powder
Extractable protein (Powdered Gloves)	No more than 120ug/dm2	No more than 120ug/dm2

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

The document does not explicitly state the sample size used for each specific test (e.g., dimensions, physical properties). It indicates that the device characteristics were "summarized below compared to ASTM and ISO standards." This implies that the testing was conducted in accordance with the methodologies and sample sizes specified within those respective standards.

Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of these tests (compliance with manufacturing and safety standards), it's highly likely they were prospective tests conducted on manufactured glove samples.

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

This information is not provided. For device testing against technical standards like ASTM and ISO, "ground truth" is established by the specifications defined in those standards, and the assessment is typically performed by trained technicians or laboratory personnel rather than clinical "experts" in the context of medical image analysis or disease diagnosis.

4. Adjudication Method for the Test Set:

This information is not provided. For standardized testing, adjudication in the sense of expert consensus on ambiguous cases is generally not applicable; rather, measurements are taken and compared directly against specified tolerances within the standards.

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 type of study was not applicable and therefore not conducted. The device in question is surgical gloves, a barrier device, not an AI-powered diagnostic or assistive tool for human readers.

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

This type of study was not applicable and therefore not conducted. The device is a physical barrier device, not an algorithm or software.

7. The Type of Ground Truth Used:

The ground truth used for performance evaluation is derived from established industry standards and specifications. Specifically:

ASTM D 3577-06: Standard Specification for Rubber Surgical Gloves. This standard dictates requirements for dimensions, physical properties (e.g., tensile strength, elongation), and freedom from holes.
ISO 10993-5/-10: Biological evaluation of medical devices. Part 5 addresses tests for in vitro cytotoxicity, and Part 10 addresses tests for irritation and skin sensitization.
ISO 11137: Sterilization of health care products — Radiation. This standard specifies requirements for the development, validation, and routine control of a sterilization process.
Specific limits for powder and extractable protein content: These are direct measurements compared against specified maximum thresholds.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a physical product (surgical gloves), not an AI model that requires a training set.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable for the same reason as above (not an AI model).

Summary

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JUL 27 2007

SHANGHAI MOTEX HEATHCARE CO., LTD.

No.369, Jiasong Zhong Road, Huaxin, Qingpu, Shanghai, 201708, China Telephone: 86-21-5979 9888 Fax: 86-21-5979 9728 E-mail: motex@public 1.sta.net.cn

દર્ 510(k) SUMMARY "

The assigned 510(k) number is : __ K063757

Submitter's Name: SHANGHAI MOTEX HEALTHCARE CO., LTD. No.369, Jiasong Zhong Road, Huaxin, Qingpu, Shanghai, 201708, China

Date summary prepared: Device Name:

November 26, 2006

Classification name: Surgeon's Gloves
. Classification number: KGO, Class I
Regulation Number: 878.4460
. Proprietary name: Motex Powder-Free Surgical Gloves & Powdered Latex Surgical Gloves
. Predicate Device: K050071. MEDISPO powdered surgeon's gloves and MEDISPO-PF powder-free surgeon's gloves

. Official Correspondent: Dr. Jen. Ke-Min

E-mail: ceirs.jen@msa.hint.net (Tel) 886-3-5208829; (Fax) 886-3-5209783 Address: No.58, Fu Chiun Street, Hsin Chu City, 30067, Taiwan, ROC

● Intended Use:

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SHANGHAI MOTEX HEATHCARE CO., LTD.

No.369, Jiasong Zhong Road, Huaxin, Qingpu, Shanghai, 201708, China Fax: 86-21-5979 9728 Telephone: 86-21-5979 9888 E-mail: motex@public1.sta.net.cn

Technological Characteristics: ●

The Motex Powder-Free Surgical Gloves & Powdered Latex Surgical Gloves characteristics are summarized below compared to ASTM and ISO standards to the predicate device:

Characteristic	Standard
Dimensions	meets ASTM D 3577-06,
Physical Properties	meets ASTM D 3577-06,
Freedom from Holes	meets ASTM D 3577-06,
Biocompatibility	meets ISO10993-5/-10
Sterilization Validation	meets ISO11137

. Clinical Data:
Not applicable.

● Conclusions:

The Motex Powder-Free Surgical Gloves & Powdered Latex Surgical Gloves and predicate devices also meet the technological characteristics of ASTM D 3577-06, ISO10993-5/-10, and ISO11137 standards. Besides, for Powder-Free SURGICAL GLOVES contain no more than 2mg powder and no more than 50ug/dm2 extractable protein, and for Powdered I.atex SURGICAL GLOVES contuin no more than 120mg powder and no more than 120ug/dm2 extractable protein claim.

Thus the new devices are substantially equivalent to the predicate devices.

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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 its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The eagle is black, and the text is in a smaller, sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 7 2007

Shanghai Motex Healthcare Company Limited C/O Dr. Jen Ke-Min Official Correspondent ROC Chinese-European Industrial No. 58, Fu Chiun Street Hsin Chu City, Taiwan 30067 CHINA

Re: K063757

Trade/Device Name: Motex Powder-Free Surgical Gloves and Powdered Latex Surgical Gloves Regulation Number: 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: June 15, 2007

Received: June 29, 2007

Dear Dr. Jen:

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 ffor 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.

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Page 2 - Dr. Jen

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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sutterf. Mckano MD

Chiu Lin, Ph.D.

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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Indications for Use

510 (K) Number ( If Known ):

Device Name: Motex Powder-Free Surgical Gloves and Powdered Latex Surgical Gloves

Indications for Use:

Prescription Use

AND/OR

Over-The-Counter Use $\sqrt{}$

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

P.4

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Page 1 of

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).