DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, BLUE COLOR
Device Facts
| Record ID | K992686 |
|---|---|
| Device Name | DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, BLUE COLOR |
| Applicant | Sheen More Ent. Co., Ltd. |
| Product Code | LZA · General Hospital |
| Decision Date | Sep 24, 1999 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6250 |
| Device Class | Class 1 |
Intended Use
A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Device Story
Disposable nitrile examination glove; blue color; worn on examiner's hand or finger. Used in medical settings to provide barrier protection; prevents cross-contamination between patient and examiner. Device is non-sterile, single-use, and powder-free.
Clinical Evidence
No clinical data provided; device is a standard patient examination glove.
Technological Characteristics
Material: Nitrile rubber. Form factor: Disposable glove, blue color, powder-free. Non-sterile.
Indications for Use
Indicated for use as a disposable patient examination glove worn by examiners to prevent cross-contamination between patient and examiner.
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
- K021001 — SHANGHAI GLOVMAX ENTERPRISE POWDERFREE BLUE NITRILE EXAMINATION GLOVES · Shanghai Glovmax Enterprise Co.,Ltd · May 16, 2002
- K220209 — Powder Free Nitrile Examination Glove, Non-sterile (Blue) · Ksg Medicare Sdn. Bhd. · Apr 11, 2022
- K153562 — Powder Free Blue Nitrile Examination Glove · Vietglove Corporation · Apr 1, 2016
- K110146 — NITRILE POWDER FREE PATIENT EXAMINATION GLOVES · Tangshan Kaiyue Glove Co., Ltd. · May 13, 2011
- K100603 — RS SAFE BLUE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE) · Riverstone Resources Sdn Bhd · Jul 16, 2010
Submission Summary (Full Text)
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Image /page/0/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 4 1999
Mr. Ken Huang Sales Manger Sheen More Enterprise Company, Limited No. 16, Tou Kung Six Road Tou-Liu Expanded Industrial Park, Tou-Liu, Yun-Lin, Taiwan
K992686 Re : Disposable Powder Free Nitrile Exam Glove, Trade Name: Blue Color Regulatory Class: I Product Code: LZA August 27, 1999 Dated: September 13, 1999 Received:
Dear Mr. Huang:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ದ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Register. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
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Page 2 - Mr. Huang
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 markets and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4690. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fday.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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- 3.0 Indications for Use Statement: Include the following or equivalent Indications for Use page, The information, data and labeling claims in the entire the 510(k) submission must support and agree with the Indications for Use statement.
INDICATIONS FOR USE
Applicant: SHEEN MORE ENTERPRISE CO.,LTD.
510(k) Number (if known): * Device Name: DISPOSABLE POWDER FREE NITRILE EXAM GLOVE,BLUE COLOR Indications For Use:
A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE I. NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)
Qhu S. Lin
(Division Sign-Off) Division of Dental, Infection Control and General Hospita 510(k) Number
Over-The-Counter
Prescription Use OR Per 21 CFR 801.109 (Optional Format 1-2-96)
- * For a new submission, do NOT fill in the 510(k) number blank.
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