This green powder-free nitrile examination glove is a disposable device made of nitrile rubber that may bear trace amount of powder and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants (21 CFR 880.6250).

Device Description

Nitrile rubber is impermeable to water and body fluids under normal conditions of use. The physical properties of the nitrile rubber enable it to conform to the hand for medical procedures. Nitrile rubber is known to form a superior barrier to bloodborne pathogens and meet physical properties for medical examination procedures as specified in ASTM D6319-00ae3.

AI/ML Overview

This document is a 510(k) submission for Green Powder-Free Nitrile Examination Gloves, identifying K041276 as the submission number. The submission outlines the device's characteristics, intended use, and a comparison to a predicate device (K030207). It includes performance data from non-clinical tests to demonstrate safety and effectiveness.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

Characteristic	Standard / Acceptance Criteria	Reported Device Performance (This Submission)	Reported Device Performance (Predicate K030207)
Freedom From Holes	ASTM D6319-00ae3, ASTM D5151-99, FDA 21 CFR 800.20	Meets	Meets
Powder-Free Residual	ASTM D6124-01	Meets, Less than 2 mg/glove	Meets, Less than 2 mg/glove
Physical Properties	ASTM D6319-00ae3	Meets	Meets
Dimensions	ASTM D6319-00ae3	Meets	Meets
Primary Skin Irritation	ISO 10993 Biological Evaluation of Medical Devices, Part 10	Passes	Not explicitly stated for predicate in table, but implied by substantial equivalence
Dermal Sensitization	Guinea Pig Sensitization, Buehler Method	Passes	Not explicitly stated for predicate in table, but implied by substantial equivalence

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

The document does not explicitly state the sample sizes for the non-clinical tests (e.g., number of gloves tested for freedom from holes or physical properties). Similarly, the country of origin for the data is not specified beyond the submitter's location in Shanghai, China. The studies described are non-clinical (laboratory testing), not human clinical trials, so the terms "retrospective" or "prospective" are not applicable in the typical sense for patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. The ground truth for these non-clinical tests is established by adherence to recognized international and national standards (ASTM, FDA, ISO) and the results obtained from standardized testing methods. There is no mention of expert consensus establishing ground truth for these specific performance characteristics.

4. Adjudication Method:

Not applicable. This is not a study involving human readers or interpretations needing adjudication. The results are based on objective measurements and adherence to specified pass/fail criteria within the standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human interpretation is involved, which is not the case for examination gloves.

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

Yes, in a sense, the tests performed are "standalone" in that they evaluate the physical and biological properties of the glove itself against established standards, without human interaction in a diagnostic or interpretive loop. The device's performance is determined solely by its material properties and manufacturing quality as measured by the specified tests.

7. The Type of Ground Truth Used:

The ground truth used for these tests is defined by:

Established Standards: ASTM D6319-00ae3, ASTM D5151-99, ASTM D6124-01, FDA 21 CFR 800.20, and ISO 10993 Part 10. These standards set the criteria for acceptable performance (e.g., maximum allowable holes, maximum powder residue, minimum physical properties like tensile strength).
Experimental Results: The outcome of the tests (e.g., whether the glove "Meets" the standard, or "Passes" irritation tests) constitutes the evidence against these standards.

8. The Sample Size for the Training Set:

Not applicable. This device is a medical glove, and the evaluation is based on non-clinical performance testing. It does not involve AI algorithms that require training sets of data.

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

Not applicable, as no training set for an AI algorithm is involved.

Summary

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Image /page/0/Picture/1 description: The image shows a sequence of handwritten digits and letters. The sequence is K041276. The characters are written in a dark ink on a white background.

510(K) SUBMISSION FOR GREEN POWDER-FREE NITRILE EXAMINATION GLOVES

ΑΤΤΑCHΜΕΝΤ Χ

510(K) SUMMARY

l. INFORMATION

SUMMITTER'S Name:	SHANGHAI MOTEX HEALTHCARE CO., LTD.
Address:	Shanghai Motex Heathcare Co., Ltd. No. 359, Jiasong Zhong Road Huaxin, Qingpu Shanghai, China 201708
Contact Person:	Tony T. K. Cheng
Phone:	86-21-59799888
Fax:	86-21-59799728
Date of Preparation:	July 14, 2004

NAME OF DEVICE

Trade or Proprietary Name:	1) Prodermic Green Powder-Free Nitrile Examination Glove 2) Multiple or Customer's Trade Names
Common or Usual Name:	Non-Sterile Nitrile Power-Free Patient Examination Glove
Classification Name:	Patient Examination Glove, Powder-Free (per 21 CFR 880.6250)

IDENTIFICATION OF THE LEGALLY MARKETED DEVICE

Class I Patient Examination Glove, 80LZA, powder-free, that meets all Olass Pration: Examination 93319-00ae3 and FDA 21 CFR 800.20.

PREDICATE DEVICE

Pro-Blue Powder-Free Medical Examination Glove, K030207

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DESCRIPTION OF DEVICE 5

a. Basis of scientific concepts for the device:
Nitrile rubber is impermeable to water and body fluids under normal Nithle rubber is impormouslations of the enable it to conform to conditions of doible manipulations for medical procedures.
b. Physical and performance characteristics such as design, material, and physical properties:
Nitrile rubber is known to form a superior barrier to bloodborne Nithle rabber is known to form a rom a specified in ASTM D6319-00ae3 nitrile pathogono and become physical properties for medical examination procedures.

INTENDED USE OF THE DEVICE 6.

This is a disposable device, intended for medical purpose, that is 1115 15 a the examiner's hand to prevent contamination between worn on the oxaminer o hander-free examination gloves are suitable in situations where powder is not desirable.

EXPLANATION OF SIMILARITIES OR DIFFERENCES TO PREDICATE DEVICE

The proposed device is substantially equivalent to the predicate device K030207 except for the following:

a) Color additive is different: green for the proposed device and blue for the predicate device.
b) The accelerators/sulfur mixture used in the predicate device has been replaced by a synthetic polymer with reactive functional groups to achieve balanced physical properties.
SUMMARY OF PERFORMANCE DATA: 11.

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510(K) SUBMISSION FOR GREEN POWDER-FREE NITRILE EXAMINATION GLOVES

1. DISCUSSION OF NON-CLINICAL TESTS

CHARACTER-ISTICS	STANDARDS	DEVICEPERFORMANCETHISSUBMISSION	DEVICEPERFORMANCEPREDICATEK030207
FreedomFrom Holes	ASTM D6319-00ae3ASTM D5151-99FDA 21 CFR 800.20	Meets	Meets
Powder-FreeResidual	ASTM D6124-01	Meets, Less than2 mg/glove	Meets, Less than2 mg/glove
PhysicalProperties	ASTM D6319-00ae3	Meets	Meets
Dimensions	ASTM D6319-00ae3	Meets	Meets

2. DISCUSSION OF ANIMAL CLINICAL TESTS

CHARATERISTICS	STANDARDS/METHODS	DEVICE PERFORMANCE
Primary SkinIrritation	ISO 10993Biological Evaluation ofMedical Devices, Part 10	Passes
Dermal Sensitization	Guinea Pig SensitizationBuehler Method	Passes

3. CONCLUSIONS DRAWN FROM NONCLINICAL AND CLINICAL TESTS THAT DEMONSTRATE SAFETY AND EFFECTIVENESS, AND PERFORMANCE =/> PREDICATE PRODUCT

The data summaries indicate that the proposed device meets the established performance standards for non-sterile powder-free patient nitrile examination gloves, and that the proposed device is substantially equivalent to predicate K030207

Pursuant to 21 C.F. R. 807.87(j), 1, Tony T.K. Cheng certify that to the best of my knowledge and belief and based upon the data and information submitted to me in the course of my responsibilities as Managing Director for the Shanghai Motex Healthcare Co., Ltd.,

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510(K) SUBMISSION FOR GREEN POWDER-FREE NITRILE EXAMINATION GLOVES

and in the reliance thereupon, the data and information submitted and in the reliance thereupon, the usual circuthful and accurate and that no
in this Premarket notification are truthful and accurate of this in this Prematket nothloation are trastral equivalence of this facts material to a review of the submission.

T. Horibe

7/14/2004
Date

Tony T.K. Cheng, Managing Director

Date

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 0 2004

Shanghai Motex Healthcare Company Limited C/O Dr. Wunan Huang At Tech, Incorporated 150J West Phillips Road Greer, South Carolina 29650

Re: K041276

Trade/Device Name: Green Nitrile Powder-Free Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: July 30, 2004 Received: August 2, 2004

Dear Dr. Huang:

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.

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Page 2 - Dr. Huang

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 (301) 594-4618. 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/dsma/dsmamain.html

Sincerely yours,

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): K041276

Device Name:__Green Nitrile Powder-Free Examination Gloves

Indications For Use: This green powder-free nitrile examination glove is a disposable device made of nitrile rubber that may bear trace amount of powder and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants (21 CFR 880.6250).

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

Over-The-Counter Use X (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


(Division Sign-Off)
Division of Anesthesiology, General Hospital.
Infection Control, Dental Devices
510(k) Number:	K041276

Regulation Number and Section

§ 880.6250 Non-powdered patient examination glove.

(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination 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). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.