(137 days)
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.
Vinyl Examination Gloves, Pre-Powdered, with Vitamin E
The provided text is a U.S. FDA 510(k) clearance letter for "Vinyl Examination Gloves, Pre-Powdered with Vitamin E." This document is a regulatory approval and does not contain information on acceptance criteria or a study proving the device meets those criteria, as requested in the prompt.
The 510(k) process primarily evaluates substantial equivalence to a legally marketed predicate device, rather than detailed performance study results against specific criteria in the way a clinical trial or a performance study for a diagnostic AI device would.
Therefore, I cannot provide the requested information based on the given text.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 5 2003
Ms. Linga Sumarta Ouality Assurance Manager Arista Latindo Industrial LTD. P.T JL. K.H. MOH. Mansyur 128 Jakarta 11210 INDONESIA
Re: K023753
Trade/Device Name: Vinyl Examination Gloves, Pre-Powdered with Vitamin E Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: March 4, 2003 Received: March 6, 2003
Dear Ms. Sumarta:
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. Sumarta
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 vou 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,
Susan Runner
Susan Runner, DDS, MA Interim 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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Image /page/2/Picture/0 description: The image shows the logo for ARISTA LATINDO INDUSTRIAL LTD. P.T., a glove manufacturer. The logo features a stylized graphic to the left of the company name. The text "GLOVE MANUFACTURER" is written in a smaller font below the company name.
MOH. MANSYUR 128 JAKARTA 11210 - INDONESIA MAILING ADDRESS : P.O. BOX 4129 JKT 11041 - INDONESIA LEPHONE : (021) 639-1907 (4 LINES) FAX : (62-21) 669-0428, 874-0979 TELEX : 42004 NIKKO IA
Section No. 3.
ATTACHMENT #2
INDICATIONS FOR USE STATEMENT
| Applicant: | PT. ARISTA LATINDO IND. LTD. |
|---|---|
| 510(k) Number (if known): | K023753 * |
| Device Name: | Vinyl Examination Gloves, Pre-Powdered, with Vitamin E |
| 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 IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use Per 21 CFR 801.109 ાર
Over-The-Counter______________________________________________________________________________________________________________________________________________________________
(Optimal Format 1-2-96)
Qlin S. Lin
Division Sign-Off vision of Anesthesiology, General Hospita Infection Control, Dental I
510(k) Number: K023753
3-1
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§ 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.