A surgeon's glove is a sterile and for single use device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The lubricating or dusting powder used in the glove is excluded.

Device Description

Motex Powder-free Nitrile Surgical Gloves are made of synthetic rubber. Thev are sterilized by radiation, and intended for be used in surgery for patient and user.

AI/ML Overview

The provided document describes the acceptance criteria and a study to demonstrate the substantial equivalence of the "Motex Powder-free Nitrile Surgical Gloves" to a predicate device, focusing on safety and effectiveness.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Characteristic	Standard/Acceptance Criteria	Reported Device Performance
Dimensions	ASTM D 3577-09e1	Meets ASTM D 3577-09e1
Physical Properties	ASTM D 3577-09e1	Meets ASTM D 3577-09e1
Freedom from Holes	ASTM D 3577-09e1	Meets ASTM D 3577-09e1
Water Leak Testing	ASTM D 5151:2006	Meets ASTM D 5151:2006
Residual Powder Testing	ASTM D 6124-06	Meets ASTM D 6124-06; values below 2mg of residual powder per glove (for "Powder-free" designation)
Water Extractable Protein Testing	ASTM D 5712-10	Meets ASTM D 5712-10
Biocompatibility	ISO10993-10/-12	Meets ISO10993-10/-12 (Gloves are non-irritating and do not display any potential for sensitization)
Sterilization Validation	ISO11137-1/-2	Meets ISO11137-1/-2 (Irradiation Sterilization)

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

The document does not explicitly state the sample sizes for each specific test mentioned (e.g., number of gloves tested for dimensions, holes, powder). The studies are primarily laboratory-based performance tests against established standards. The provenance of the data is from Shanghai, China, where the manufacturer (Shanghai Motex Healthcare Co., Ltd.) is located. These are likely retrospective tests conducted on manufactured batches to ensure compliance with the standards.

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 in the context of this device. The "ground truth" for these types of medical devices is established by adherence to internationally recognized consensus standards (ASTM, ISO). These standards define the acceptable range or threshold for each characteristic, and laboratories perform tests to measure these characteristics against those predefined limits. There isn't a team of experts adjudicating individual glove results in the same way a medical image might be reviewed.

4. Adjudication method for the test set:

This is not applicable. As mentioned above, the assessment is against established objective technical standards, not subjective expert judgment that would require adjudication.

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 is not applicable. This document describes a surgical glove, not an AI-powered diagnostic or assistive device. Therefore, no MRMC study or AI assistance assessment was conducted.

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

This is not applicable. This device is a physical medical device (surgical glove), not a software algorithm.

7. The type of ground truth used:

The ground truth used is based on established industrial and medical device standards (ASTM, ISO). These standards define the limits and methodologies for testing physical properties, safety (biocompatibility), and sterility of surgical gloves.

8. The sample size for the training set:

This information is not applicable. This product is a physical device, not an AI or machine learning 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 point 8.

Summary

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

Telephone: 86-21-5979 9888 Fax: 86-21-23010718

II. 510(K) Summary of Safety and Effectiveness (Per 21 CFR 807.92)

2.1. General Information Establishment

E Manufacturer: Shanghai Motex Healthcare Co., Ltd.
li Address: No.369, Jiasong Zhong Road. Huaxin, Qingpu, Shanghai, 201708, China
동 Owner Number: 9041164 9615978 Registration Number:
일 Contact Person: Dr. Jen, Ke-Min

E-mail: ceirs.jen@msa.hinet.net Tel: 886-3-5208829 : Fax: 886-3-5209783

Date Prepared: August 1, 2012

Device

Proprietary Name: Motex Powder-free Nitrile Surgical Gloves Item 6610 White Motex Powder-free Nitrile Surgical Gloves Item 6610 Green

Motex Powder-free Nitrile Surgical Gloves Item 6710 Green
. Common Name: Surgeon's glove
. Classification Name: Surgeon's glove
. Product Code:

OCT 0.3 2013

Regulation Number: KGO. Class 1, 878,4460

2.2. Safety and Effectiveness Information

. Predicate Device:

Claim of Substantial Equivalence (SE) is made to Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating (K102500)

● Device Description:

Motex Powder-free Nitrile Surgical Gloves are made of synthetic rubber. Thev are sterilized by radiation, and intended for be used in surgery for patient and user.

9 Device Characteristics:

Single use only.

Not made with natural rubber latex.

● Technological Characteristics:

Motex Powder-free Nitrile Surgical Gloves characteristics are summarized below . compared to ASTM and ISO standards to the predicate device:

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

SHANGHAI MOTEX HEATHCARE CO., LTD.

No.369, Jiasong Zhong Road, Huaxin, Qingpu, Shanghai, 201708, China Fax: 86-21-23010718 Telephone: 86-21-5979 9888

Characteristic	Standard
Dimensions	ASTM D 3577-09e1
Physical Properties	ASTM D 3577-09e1
Freedom from Holes	ASTM D 3577-09e1
Water leak testing	ASTM D 5151:2006
Residual powder testing	ASTM D 6124-06
Water extractable protein testing	ASTM D 5712-10
Biocompatibility	ISO10993-10/-12
Sterilization Validation	ISO11137-1/-2

� Powder Residual:

Surgeon's gloves meet powder level requirements for "Powder-free" designation per ASTM D6124. Standard test method for residual powder on medical gloves. The results generated values will below 2mg of residual powder per glove.

● Clinical Data:

Not applicable.

� Indications for Use:

. Substantial Equivalence (SE)

A claim of substantial equivalence is "Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating" (K102500). Both of the subject device and predicate device have the same indications for use, material composition with Nitrile, meet the performance tests by ASTM D3577, powder residual by ASTM D6124, and also completed the biocompatibility, sterilization validation test reports. The major differences are the subject devices have different colorants for two items, including 6610 White, 6610 Green, and 6710 Green; and the specifications are 6~8.5 size. In addition, the predicate device is made with neoprene and coated with nitrile, while the subject device is made solely with These differences are not relating to the safety or effectiveness nitrile rubber. Thus thev are substantially equivalent. aspects.

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

SHANGHAI MOTEX HEATHCARE CO., LTD.

No.369, Jiasong Zhong Road, Huaxin, Qingpu, Shanghai, 201708, China Telephone: 86-21-5979 9888 Fax: 86-21-23010718

Comparison to Legally Marketed Device

Comparison Feature	Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating(K102500)	Motex Powder-free Nitrile Surgical Gloves(K122557)
Indications For Use	Those powder-free sterile surgeon's gloves are a disposable devices made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination in the environments within hospitals and other healthcare facilities.	A surgeon's glove is a sterile and for single use device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The lubricating or dusting powder used in the glove is excluded.
Prescription/OTCDevice	Over-the-Counter Use	Same
Product code	KGO, Class 1, 878.4460	KGO, Class I, 878.4460
Intended Use	Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination in the environments within hospitals and other healthcare facilities.	Sterile disposable devices made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
MaterialComposition	Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating	Powder-Free Nitrile Surgical Gloves
Performance Testfor Pinhole,Dimensions, andPhysical properties	Meets ASTM D3577	Same
Powder Residual	Results generated values below 2mg of residual powder per glove	Meets ASTM D6124Same
Biocompatibility	Gloves are non-irritating.Gloves do not display any potential for sensitization.	Meets ISO10993-10/-12Same
SterilizationMethod	Irradiation Sterilization	Meets ISO11137-1/-2Same
Product Trade Name	Sterile Neoprene Powder-FreeSurgical Gloves with Nitrile Coating	Motex Powder-free Nitrile SurgicalGlovesItem: 6610_White, 6610_Green, and6710 Green
Device Design	Made with neoprene and coatedwith nitrile; and it is powder-freeand sterile.	Made solely with nitrile rubber; and itis powder-free and sterile.
Color of the Devices	No prior information	White and Green
Specification size	No prior information	6, 6.5, 7, 7.5, 8, 8.5
Water ExtractableProtein Testing	No prior information	Meets ASTMD5712

Similarity:

{3}------------------------------------------------

SHANGHAI MOTEX HEATHCARE CO., LTD.

No.369, Jiasong Zhong Road, Huaxin, Qingpu, Shanghai, 201708, China Telephone: 86-21-5979 9888 Fax: 86-21-23010718

Difference:

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image contains a logo for the Department of Health and Human Services (DHHS) in the USA. The logo features the DHHS emblem, which consists of a stylized human figure with three arms reaching upwards, symbolizing health, services, and people. The emblem is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Humpshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

October 3, 2013

Shanghai Motex Healthcare Company, Limited Dr. Jen, Kc-Min Official Correspondent 369 Jiasong Zhong Road Huaxin, Qingpu. Shanghai 201708 CHINA

Re: K122557

Trade/Device Name: Motex Powder-free Nitrile Surgical Gloves Item 6610 White Motex Powder-free Nitrile Surgical Gloves Item 6610 Green Motex Powder-free Nitrile Surgical Gloves Item 6710 Green

Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: September 18, 2013 Received: September 25, 2013

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 (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 10 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 upproval 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. Iisting 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.

{5}------------------------------------------------

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/Safetw/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours, Teiashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID FOR Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

Indications for Use

510 (K) Number ( If Known ):__K122557

Device Name: Motex Powder-free Nitrile Surgical Gloves Item 6610 White Motex Powder-free Nitrile Surgical Gloves Item 6610 Green Motex Powder-free Nitrile Surgical Gloves Item 6710 Green

Indications for Use:

Prescription Use (21 CFR Part 801 Subpart D) AND/OR

ਵ Over the Counter Use __ (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth F. Claverie 2013.10.02 17:29:07 -04'00'

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

510(k) __K122557

Page_ 1 of _1

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).