(87 days)
A surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination
pre-POWDERED LATEX SURGEON'S GLOVES
This document is a 510(k) clearance letter from the FDA for Sanrea Healthcare Private Limited's "Pre-Powdered Latex Surgeon's Gloves." It does not contain information on acceptance criteria, study data, or AI-related performance. Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details. This document is solely an FDA clearance for marketing the device based on substantial equivalence to a predicate device.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jose Paul M. Sanrea Healthcare Private Limited Plot No. 14-C. Cochin Special Economic Zone, Kakkanad, Cochin, Kerala 682037 INDIA
JAN 16 2003
Re: K023515
Trade/Device Name: Pre-Powdered Latex Surgeon's Gloves Regulation Number: 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: December 14, 2002 Received: December 23, 2002
Dear Mr. Jose Paul M:
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 - Mr. Jose Paul M
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 vour 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. 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" (21CFR Part 807.97) you may obtain. Other general information on vour responsibilities under the Act may be obtained 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,
Timothy A. Ulatowski 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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IREA HEALTHCARE PRIV/
PLOT NO. 14-C, COCHIN SPECIAL ECONOMIC ZONE, KAKKANAD, COCHIN 0: 422514, 422826, 423211, Fax. 91484 - 422541 , Email: sanreal@vsni.net
ENCLOSURE-II
INDICATIONS FOR USE
| APPLICANT | SANREA HEALTHCARE PRIVATE LIMITED |
|---|---|
| 510 (k) NO | K023515 |
| DEVICE NAME | pre-POWDERED LATEX SURGEON'SGLOVES |
INDICATIONS FOR USE.
A surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Qun S. Lin
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K023515
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).