POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINES 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACE
Device Facts
| Record ID | K030583 |
|---|---|
| Device Name | POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINES 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACE |
| Applicant | Shen Wei (Usa), Inc. |
| Product Code | LYY · General Hospital |
| Decision Date | Nov 10, 2003 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6250 |
| Device Class | Class 1 |
Intended Use
a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is not intended to be used as a chemical barrier.
Device Story
Textured powder-free latex examination glove; blue color; contains 50 micrograms or less of total water extractable protein per gram. Used in clinical settings by healthcare professionals to provide a physical barrier against contamination between patient and examiner. Device is disposable and non-sterile. Not intended for chemical protection.
Clinical Evidence
bench testing only
Technological Characteristics
Material: Latex. Form factor: Textured, powder-free, blue color. Protein content: 50 micrograms or less of total water extractable protein per gram. Regulatory class: I. Product code: LYY.
Indications for Use
Indicated for use as a disposable medical glove worn on the examiner's hand to prevent cross-contamination between patient and examiner. Not for use as a chemical barrier.
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.
Related Devices
- K991750 — BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDER FREE CONTAINING 50 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN · Brightsway Holdings Sdn Bhd · Jun 23, 1999
- K991752 — BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDERED CONTAINING 150 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN PE · Brightsway Holdings Sdn Bhd · Jun 23, 1999
- K031414 — POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), OR BLUE COLORED, WITH EXTRACTABLE PROTEIN CONTENT LABE · Perusahaan Getah Asas Sdn. Bhd. · Jun 26, 2003
- K022815 — MULTIPLE PATIENT EXAMINATION GLOVES POWDERED LATEX · Pt. Smartglove Indonesia · Feb 13, 2003
- K993621 — HEALTH-PLUS, SANITEX, RELIANCE, BLUE PRE-POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (100 MIC · Pamitex Industries Sdn Bhd · Dec 29, 1999
Submission Summary (Full Text)
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 9 2003
Ms. Belle L. Chou General Manager Shen Wei (USA), Incorporated 2845 Whipple Road Union City, California 94587
Re: K030583
Trade/Device Name: Textured Powder -Free Latex Examination Glove with Protein Labeling Claim (Contains 50 Micrograms or less of total water extractable Protein Per Gram), Blue Color Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: September 1, 2003 Received: September 3, 2003
Dear Ms. Chou:
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 - Ms. Chou
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,
Ques
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
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K030583
Image /page/2/Picture/1 description: The image shows the logo for Shen Wei Inc. The logo consists of a stylized "S" shape formed by two curved black shapes stacked vertically. Below the symbol, the text "SHEN WEI INC." is arranged in three lines, with each word centered. The font is a simple, sans-serif typeface.
## K030583
## Attachment Two
## INDICATION FOR USE
Shen Wei (USA) Inc. Applicant:
- Device Name: Textured Powder-Free Latex Examination Gloves with Protein Labeling Claim (contains 50 micrograms or less of total water extractable protein per gram), Blue Color
Indication For Use:
a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
This device is not intended to be used as a chemical barrier.
## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Pat. Atty. Andrew Arnold Clay, Jr. 1/14/63
510(k) Number: K030583
Prescription Use Per 21CFR 801.109 OR
Over-The Counter (Optional Format 1-2-96)
