PRE-POWDERED NITRILE EXAMINATION GLOVES

K974442 · P.T. Latexindo Tobaperkasa · LZY · Jan 5, 1998 · Orthopedic

Device Facts

• Record ID: K974442
• Device Name: PRE-POWDERED NITRILE EXAMINATION GLOVES
• Applicant: P.T. Latexindo Tobaperkasa
• Product Code: LZY · Orthopedic
• Decision Date: Jan 5, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3360
• Device Class: Class 2

Intended Use

A Medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.

Device Story

Pre-powdered nitrile examination glove; serves as protective barrier for healthcare personnel; worn on hands to prevent cross-contamination between patient and provider; used in clinical or similar settings; disposable; non-sterile; provides physical barrier against contaminants.

Clinical Evidence

Bench testing only.

Technological Characteristics

Material: Nitrile rubber; Form factor: Examination glove; Surface: Pre-powdered; Class I medical device; non-sterile.

Indications for Use

Indicated for use by healthcare 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 hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. Hendra Ramali
President Director
P.T. Latexindo Tobaperkasa
Jalan Raya Binjai Km. 11
Medan 20128, Indonesia

Re: K974442
Trade Name: Pre-Powdered Nitrile Examination Gloves
Regulatory Class: I
Product Code: LZY
Dated: November 25, 1997
Received: November 25, 1997

Dear Mr. Ramali:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Ramali

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

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

Enclosure

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P.T. LATEXINDO TOBAPERKASA
Jalan Raya Binjai Km. 11, Medan 20128, Indonesia
Tel. [phone] / 861471 / 868856 Fax. [phone]
E-mail: [e-mail]
Attachment G

## Indication For Use Statement

510(K) Number (if known): K974442
Device Name: Pre-powdered Nitrile Examination Gloves

Indication For Use:
A Medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.

PT. Latexindo Tobaperkasa
*(Handwritten signature)*

Hendra Ramali
President Director
*(Handwritten signature)*

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

(Division Sign-Off)
Division of Dental, Infection Control, and General Health Office of Device Evaluation (ODE)
510(k) Number K974442

Prescription Use ☐ or Over-The-Counter Use ☑
(Per 21 CFR 801.109)

(Optimal Format 1-2-96)