(42 days)
A glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
Powder-Free Multi-Ply Latex Examination Gloves With Protein Labeling Claim ( 50 Micrograms or Less )
I am sorry, but based on the provided document, I cannot extract the information required to answer your request. The document is a 510(k) premarket notification letter from the FDA regarding "Powder-Free Multi-Ply Latex Examination Gloves With Protein Labeling Claim (50 Micrograms or Less)."
This document primarily focuses on the regulatory approval of a medical device (examination gloves) and does not contain details about:
- Acceptance criteria and reported device performance in a table format.
- Specific studies, sample sizes, data provenance, ground truth establishment, or expert qualifications.
- Adjudication methods or multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance or training set details.
The document is a letter confirming substantial equivalence to a predicate device, which is a regulatory pathway for certain medical devices, rather than a detailed study report.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three stylized lines forming its body and wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 4 2002
Mr.Tan Swu Choon
Syntex Healthcare Products Company Limited No. 1 Fanjiazhung Industrial Zone Xinji City, Hebei Province, P. R. CHINA 052360
Re: K021058
Trade/Device Name: Powder-Free Multi-Ply Latex Examination Gloves With Protein Labeling Claim ( 50 Micrograms or Less ) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: March 14, 2002 Received: April 2, 2002
Dear Mr. Choon:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviously our because of 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 Interstate commerce proc to ria, ac, ac, ac, ac, ac, accordance with the provisions of Amendinene, or to do rough 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 approval approvision (1772). The general controls provisions of the Act include controls provided 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 If your device to subject to such additional controls. Existing major regulations affecting (1 NE ), it neg ob 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. Choon
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA s issualites of a successor as vith other requirements
mean that FDA has made a determination that your devices with other Federal agencies mean that FDA has made a delectimation that your and inistered by other Federal agencies.
of the Act or any Federal statutes and regulations and not limited to: registration of the Act or any Federal statues and registered sincluding, but not limited to: registration
You must comply with all the Act 's requirements , actuation practice You must comply with an the Act 3 requirements integral manufacturing practice and listing (21 CPR Part 807), laoching (21 CF (CF (CFR Pat 820); and if
requirements as set forth in the quality systems (QS) regulation (21 -542 of the Ar requirements as set form in the quality systems (Sections (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 This letter will allow you to begill maketing your do routstantial equivalence of your device to
510(k) premarket notification. The FDA finding of substantial equivalence an 510(k) premarket noutication. The I Driving of cation 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 If you desire specific advice for your do rio in vitro diagnostic devices), please contact the and additionally 21 CFK Patt 807.10 for in Virginally, for questions on the promotion and
Office of Compliance at (301) 594-4618 . Office of Compliance at (301) 594-4010 : Trumbliance at (301) 594-4639.
advertising of your device, please contact the Office of Compliance as promories Also, please note the regulation entitled, "Misbranding by reference to premarket Also, please note the regulation onlined as a secral information on your responsibilities under
notification" (21CFR Part 807.97). Other general informational and notification" (ZICFK Part 807.97). Other general Manufacturers, International and the Act may be obtained from the Drivision of 0126 638-2041 or (301) 443-6597 or at its
Consumer Assistance at its toll-free number (800) 638-2041 de mana in . http:/ Consumer Assistance at its ton iro annova (cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Runner
Timothy A. Ulatowski 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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KO2105B 510(K) Number (if known): _
Device Name
Powder-Free Multi-Ply Latex Powder-Free Multi-Ply Lates tion Glove rain or less)
Indication For Use :
A glove is worn on the hand of healthcare worker and Similar personnel to prevent contamination between healthcare
similar personnel to prevent contamination between healthcare similar personnel to prevent collianination books.
personnel and the patient's body, fluids, waste or environment.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ANOTHER PAGE IF NEEDED)
THE CONTINUE CONTINUE CODRH, Office of Device Evaluation (ODE) NOT WRITE BELOW THIS LINE-CONTINOBY.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Abby Chin
(Printing Sign Off)
Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices *02 1058 510(k) Number ________________________________________________________________________________________________________________________________________________________________
OR Over The Counter Use_
(Optional Format 1-2-95)
Prescription Use: (Per 21 CFR 801.109)
§ 880.6250 Non-powdered patient examination glove.
(a)
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.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.