NON-STERILE, POWDER-FREE, BLACK NITRILE EXAMINATION GLOVES

K072400 · Sgmp Co., Ltd. · LZA · Mar 27, 2008 · General Hospital

Device Facts

• Record ID: K072400
• Device Name: NON-STERILE, POWDER-FREE, BLACK NITRILE EXAMINATION GLOVES
• Applicant: Sgmp Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Mar 27, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Non-sterile Powder Free Black Nitrile Examination Gloves , 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.

Device Story

Non-sterile, powder-free black nitrile examination glove; worn by healthcare personnel on hands or fingers; acts as a physical barrier to prevent contamination between patient and examiner; disposable; manufactured to meet ASTM D6319-00aE3 standards.

Clinical Evidence

No clinical data. Evidence consists of bench testing including water leak tests (ASTM D5151-06), residual powder testing (ASTM D6124-06), and biocompatibility testing on rabbits and guinea pigs.

Technological Characteristics

Nitrile examination glove; powder-free; meets ASTM D6319-00aE3 standard specification; biocompatible; non-sterile.

Indications for Use

Indicated for use by healthcare and similar personnel as a disposable medical glove worn on the hand or finger to prevent cross-contamination between the examiner and the patient.

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

• POWDER FREE BLUE NITRILE EXAM GLOVES (K000868)

Submission Summary (Full Text)

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## MAR 2 7 2008

APPENDIX K

### K072400 510(k) SUMMARY SUMMARY OF THE SAFETY AND EFFECTIVENESS FOR NON-STERILE, POWDER FREE BLACK NITRILE EXAMINATION GLOVES

Submitted For : SGMP Company Limited, 181 Moo 6, Tambol Kampacngpotch, Rattaphum, Songkhla 90180, Thailand.

Tucker & Associates Submitted By: Official Correspondent for SGMP Co Ltd Janna P. Tucker, President - CRO 198 Avenue de la D'emerald, Sparks, NV 89434-9550 Phone No : 775-342-2612 Fax No : 775-342-2613 E-mail: [e-mail]

Equivalent Predicate Device: PQWDER FREE BLUE NITRILE EXAM GLOVES which was granted a 510(k) # K000868

This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

#### Device Information:

Trade Name - Non-Sterile, Powder Free Black Nitrile Exammation Gloves

### Common Name - Exam gloves

Classification Name - Patient examination glove (per 21 CFR 880.6250)

Classification Information - Class I Nitrile examination glove 80LZA, powder free and meeting all the requirements of ASTM D6319-00aE3 Standard Specification for Nitrile Examination Gloves for Medical Application.

### Device Description:

Class I Nitrile examination gloves 80LZA, powder free and meeting all the requirements of ASTM D6319-00aE3 Standard Specification for Nitrile Examination Gloves for Medical Application.

### Intended Use of Device:

A medical glove to be worn on the hand of the health care and similar porsomnel to prevent contamination between health care personnel and patient.

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#### Conclusion:

The data presented indicate the Non-sterile Powder-Free Black Nitrile Examination Glove meets the following Standards:

- ASTM D6319-00aE3, Standard Specification For Nitrile Gloves. 】.
- 1SO 2859-1, Standard for Water Leak Test and/or ASTM D5151-06, Standard Test Method for 2. Detection of Holes in Medical Gloves.

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- 3. ASTM D6124-06, Sundard Test Method for Residual Powder on Medical Gloves.
- 4. Biocompatibility Testing on White rabbits and Guinea Pigs.
- ડ. Labeling meets FDA Specifications
- હ. Except for Color, this glove is equivalent to K000868.

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APPENDIX K

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAR 2 7 2008

SGMP Company, Limited C/O Ms. Janna P. Tucker Official Correspondent/ United States Agent Tucker & Associates 198 Avenue De La D' Emerald Sparks, Nevada 89434-9550

Re: K072400

Trade/Device Name: Non-Sterile, Powder Free Black Nitrile Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: March 11, 2008 Received: March 13, 2008

Dear Ms. Tucker:

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 Eederal Register.

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Page 2 - Ms. Tucker

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/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

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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# INDICATION FOR USE STATEMENT

Applicant : SGMP Company Limited

510K NUMBER Dr

11072400

Device Name : Non-Sterile, Powder Free Black Nitrile Examination Gloves

Indication For Use :

The Non-sterile Powder Free Black Nitrile Examination Gloves , 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.

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

Over-The-Counter .... 21 CFR 801 Subpart C

.............................................................................................................................................................................. Concurrence of CDRH , Office of Device Evaluation (ODE)

Sheila H. Murphy, KD

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

510(k) Number: K072400