AURELIA CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA AND GINSENG WITH PROTEIN LABELING CLAIM

K013953 · Supermax Glove Manufacturing Sdn Bhd · LYY · Feb 26, 2002 · General Hospital

Device Facts

• Record ID: K013953
• Device Name: AURELIA CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA AND GINSENG WITH PROTEIN LABELING CLAIM
• Applicant: Supermax Glove Manufacturing Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: Feb 26, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A medical examination glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Device Story

Device is a powder-free, chlorinated latex medical examination glove coated with aloe vera and ginseng. Used by healthcare personnel in clinical settings as a protective barrier to prevent cross-contamination between the wearer and the patient. Features a protein labeling claim of 50 micrograms or less. Device is a physical barrier; no electronic or software components.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Material: Latex. Form: Powder-free, chlorinated. Additives: Aloe vera and ginseng. Protein content: 50 micrograms or less. Regulatory Class: I. Product Code: LYY.

Indications for Use

Indicated for use by health care and similar personnel as a protective barrier worn on the hands to prevent cross-contamination between the personnel and the patient.

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

# FEB 2 6 2002

Mr. Stanley Thai Managing Director Supermax Glove Manufacturing Sdn. Bhd. Lot 42, Putra Industrial Park Bukit Rahman Putra Sungai, Buloh, Selangor, MALAYSIA

### Re: K013953

Trade/Device Name: Aurelia Chlorinated Powder Free Latex Medical Examination Gloves with Aloe Vera and Ginseng with Protein Labeling Claim (50 Micrograms or Less) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: November 28, 2001 Received: November 30, 2001

### Dear Mr. Thai:

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. Thai

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 you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR 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]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

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Sincerely yours,

Timothy A. Ulatowski
Director
Division of Dental, Infection Control
and General Hospital Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Radiological Health

#### Enclosure

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## INDICATIONS FOR USE

| Applicant : | Supermax Glove Manufacturing Sdn. Bhd. |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| 510 (k) Number (if known) : | K 013953 |
| Device Name : | Aurelia Chlorinated Powder Free Latex Medical Examination Gloves with Aloe Vera and Ginseng with Protein label claim (50 microgram or less) |

Indications For Use :

A medical examination glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

and the same of the same of the same of the same of the same of

Concurrence of CDRH Office of Device Evaluation (ODE)

| Prescription Use<br>Per 21 CFR 801.109) | |
|-----------------------------------------|--|
| OR | |
| Over-The-Counter | |

| Division Sign-Off | |
|--------------------------------------------------------------------|---------|
| Division of Dental, Infection Control,<br>General Hospital Devices | |
| Number | K013953 |

(Optional Format 1-2-96)