CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES (YELLOW)

K050277 · Hartalega Sdn Bhd · LYY · Jun 7, 2005 · General Hospital

Device Facts

• Record ID: K050277
• Device Name: CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES (YELLOW)
• Applicant: Hartalega Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: Jun 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The latex examination gloves is a disposable devices intended for medical, dental and laboratory purposes that is worn on the mcarear, achear and to prevent contamination between patient and examiner.

Device Story

Chlorinated powder-free latex examination gloves; disposable protective barrier; worn on hands by medical, dental, and laboratory personnel; prevents cross-contamination between patient and examiner; manufactured from natural rubber latex; chlorinated to reduce powder/protein content; intended for single-use.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Material: Natural rubber latex. Form factor: Disposable examination glove. Processing: Chlorinated to remove powder and reduce residual proteins. Energy source: None. Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for use as a disposable protective barrier worn on the hands by medical, dental, and laboratory personnel 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services, USA. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the snake and staff. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the caduceus.

Public Health Service

JUN 7 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Nurul Aisyah Kong Quality Assurance Manager Hartalega Sdn. Bhd. Lot 9, Jalan Kuang Bulan, Taman Kepong Industial Estate, 52100 Kuala Lumpur MALAYSIA

Re: K050277

Trade/Device Name: Chlorinated Powder Free Latex Examination Gloves (Yellow) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: May 26, 2005 Received: June 3, 2005

Dear Ms. Kong:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your ea your entermined 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 mendments, or to devices that have been reclassified in accordance with the provisions of Antichunches, or to devroos and Cosmetic Act (Act) that do not require approval of a premarket the rederal I vou, Drag, Drag, therefore, market the device, subject to the general approvin apprevailed (the Act. The general controls provisions of the Act include controls providens or the ristration, 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 (1 Mr.), it may be back of Federal Regulations, Title 21, Parts 800 to 898. In your device can or found in the be as nouncements concerning your device in the Federal Register.

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## Page 2 - Ms. Kong

Please be advised that FDA's issuance of a substantial equivalence determination does not Please oe advised that I DT is issuaires on that your device complies with other requirements Incall that I DAT has made a autes and regulations administered by other Federal agencies. of the Act of ally I oderal barrequirements, including, but not limited to: registration 1 ou must comply with an art any fabeling (21 CFR Part 801); good manufacturing practice and listing (21 CF R Pact 807), lability systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality of 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) I mis letter will and w yourse of substantial equivalence of your device to a promatice notification. - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 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 at the Office of Compliance at [phone]. 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 may obtain other general misternational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jenice K. Michie OMD

Chiu Lin, Ph.D. 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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## Indications for Use

510(k) Number (if known): K050277

Device Name: Chlorinated Powder Free Latex Examination Gloves (Yellow)

Indications For Use:

The latex examination gloves is a disposable devices intended for medical, dental and laboratory purposes that is worn on the mcarear, achear and to prevent contamination between patient and examiner.

Prescription Use (Part 21 CFR 801 Subpart D)

11/12/11/2017 11:51:14

AND/OR

Over-The-Counter Use __x__ (21 CFR 801 Subpart C)

17/13

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

Concurrence of CDRH, Office of Device Evaluation (ODE.)

Shula P. Murphy, 6

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

510(k) Number. K030277