LAGLOVE BRAND NITRILE EXAMINATION GLOVES POWDERED, NON STERILE (PINK COLOR)

K092498 · La Glove (M) Sdn. Bhd. · LZA · Nov 20, 2009 · General Hospital

Device Facts

• Record ID: K092498
• Device Name: LAGLOVE BRAND NITRILE EXAMINATION GLOVES POWDERED, NON STERILE (PINK COLOR)
• Applicant: La Glove (M) Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Nov 20, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

Laglove TM Brand Nitrile Examination Gloves, Powdered, Non - Sterile (Pink Color) is a patient examination glove is a disposable device intended for medical purpose worn on the examiners hand or finger to prevent contamination between patient and examiner.

Device Story

Laglove Brand Nitrile Examination Gloves are disposable, non-sterile, powdered nitrile gloves. Used in medical settings by clinicians to cover hands or fingers. Primary function is to act as a physical barrier to prevent cross-contamination between patient and examiner during examinations. Device is a single-use, patient-contact accessory.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Nitrile rubber material; powdered; non-sterile; disposable; form factor is a hand-worn glove; Class I medical device.

Indications for Use

Indicated for use as a disposable patient examination glove worn by examiners 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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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

## FEB 2 2 2010

Mr. G. Baskaran Group Managing Director Laglove (M) Sdn. Bhd Lot 478, Jalan Simpang Balak Off Batu 13, Jalan Cheras, 43000 Kajang Selangor Darul Ehsan MALAYSIA

Re: K092498

Trade/Device Name: Laglove™ Brand Nitrile Examination Gloves, Powdered, Non- Sterile (Pink) Regulation Number: 21CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: October 9, 2009 Received: October 19, 2009

Dear Mr. Baskaran:

This letter corrects our substantially equivalent letter of October 9, 2009.

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.

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.

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Page 2- Mr. Baskaran

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for

Anthony D. Watson, BS, MS, MBA 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 3.0

| Applicant | : LAGLOVE (M) SDN. BHD. |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | : K092498 |
| Device name | : Laglove TM Brand Nitrile Examination<br>Gloves, Powdered, Non-Sterile.<br>(Pink Color) |
| Indications for use | : Laglove TM Brand Nitrile Examination<br>Gloves, Powdered, Non - Sterile<br>(Pink Color) is a patient examination<br>glove is a disposable device intended for<br>medical purpose worn on the examiners<br>hand or finger to prevent contamination<br>between patient and examiner. |

Preseription Use (Part 21 GFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth F. Clunie-Wells

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

510(k) Number: K092498

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01/13/10 5 Doc. Ref. : LG/510(k)/NExPWPK