POWDER-FREE NITRILE EXAMINATION GLOVES

K041276 · Shanghai Motex Healthcare Co., Ltd. · LZA · Aug 20, 2004 · General Hospital

Device Facts

• Record ID: K041276
• Device Name: POWDER-FREE NITRILE EXAMINATION GLOVES
• Applicant: Shanghai Motex Healthcare Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Aug 20, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended 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).

Device Story

Disposable nitrile rubber examination glove; worn on hands/fingers by medical personnel; provides barrier against infectious materials and contaminants; used in clinical settings; prevents cross-contamination between examiner and patient. Device is non-sterile and powder-free.

Clinical Evidence

No clinical data. Evidence consists of bench testing and biocompatibility studies. Bench testing included freedom from holes (ASTM D5151-99), powder-free residual (ASTM D6124-01), physical properties, and dimensions (ASTM D6319-00ae3). Biocompatibility testing included primary skin irritation and dermal sensitization (Guinea Pig Buehler Method) per ISO 10993.

Technological Characteristics

Nitrile rubber material; powder-free; non-sterile. Complies with ASTM D6319-00ae3 for physical properties and dimensions, ASTM D5151-99 for freedom from holes, and ASTM D6124-01 for powder residual. Biocompatibility per ISO 10993. No electronic or software components.

Indications for Use

Indicated for use as a disposable, non-sterile, powder-free nitrile rubber glove worn on the hand or fingers by medical personnel to provide a barrier against infectious materials and contaminants.

Regulatory Classification

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.

Predicate Devices

• Pro-Blue Powder-Free Medical Examination Glove (K030207)

Submission Summary (Full Text)

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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<br>-ISTICS | STANDARDS | DEVICE<br>PERFORMANCE<br>THIS<br>SUBMISSION | DEVICE<br>PERFORMANCE<br>PREDICATE<br>K030207 |
|-------------------------|--------------------------------------------------------|---------------------------------------------|-----------------------------------------------|
| Freedom<br>From Holes | ASTM D6319-00ae3<br>ASTM D5151-99<br>FDA 21 CFR 800.20 | Meets | Meets |
| Powder-Free<br>Residual | ASTM D6124-01 | Meets, Less than<br>2 mg/glove | Meets, Less than<br>2 mg/glove |
| Physical<br>Properties | ASTM D6319-00ae3 | Meets | Meets |
| Dimensions | ASTM D6319-00ae3 | Meets | Meets |

# 2. DISCUSSION OF ANIMAL CLINICAL TESTS

| CHARATERISTICS | STANDARDS/METHODS | DEVICE PERFORMANCE |
|----------------------------|-------------------------------------------------------------------|--------------------|
| Primary Skin<br>Irritation | ISO 10993<br>Biological Evaluation of<br>Medical Devices, Part 10 | Passes |
| Dermal Sensitization | Guinea Pig Sensitization<br>Buehler 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 [phone]. 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 [phone] or [phone] 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)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <img alt="signature" src="signature.png"/> |
|-----------------------------------------------|--------------------------------------------|
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital. | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K041276 |