ON-LINE POWDER-FREE LATEX EXAMINATION GLOVE, TYPE II,LOW MODULUS, WITH PROTEIN LABELING CLAIM

K030331 · Perusahaan Getah Asas Sdn. Bhd. · LYY · Mar 21, 2003 · General Hospital

Device Facts

• Record ID: K030331
• Device Name: ON-LINE POWDER-FREE LATEX EXAMINATION GLOVE, TYPE II,LOW MODULUS, WITH PROTEIN LABELING CLAIM
• Applicant: Perusahaan Getah Asas Sdn. Bhd.
• Product Code: LYY · General Hospital
• Decision Date: Mar 21, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

A 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.

Device Story

On-line Powder-free Latex Patient Examination Glove is a disposable, low-modulus latex glove. Used by healthcare professionals in clinical settings to provide a protective barrier between the examiner and patient, reducing risk of cross-contamination. Device features a labeling claim for extractable protein content of 50 micrograms per gram or less. Operation is manual; device is donned by the user.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Latex. Type: Powder-free, low modulus. Protein content: 50 micrograms per gram or less. Form factor: Disposable patient examination glove. Sterilization: Not specified.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger 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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Perusahaan Getah Asas Sdn Bhd C/O Mr. James F. Logan Medical Reports Exchange 1301 Defence Highway Gambrills, Maryland 21054

Re: K030331

Trade/Device Name: On-line Powder-free Latex Patient Examination Gloves, Type II, Low Modulus with Extractable Protein Content Labeling Claim (50 Micrograms per gram or less) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: January 28, 2003 Received: January 31, 2003

Dear Mr. Logan:

This letter corrects our substantially equivalent letter of March 21, 2003 regarding the device name.

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 (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.

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Page 2 - Mr. Logan

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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 continue 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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number [phone] or at [phone] 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

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Section 3 , rev. 1, K030331

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510 (K) Number (if known) :

Device Name : On-line Powder-free Latex Patient Examination Glove. Type II. Low Modulus, with extractable protein content labelling claim ( 50 microgram per gram of glove or less)

Indications For Use

A 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.

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Concurrence of CDRH . Office of Device Evaluation (ODE)

Prescription Use ( Per 21 CFR 801. 109 ) ()ર

Over-The-Counter Use

( Optional Format 1-2-96 )

Chin S. Lim

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Den

510(k) Number: K030331