Pre-Powdered Nitrile Examination Gloves

FDA 510(k) K974442 · P.T. Latexindo Tobaperkasa

Substantially Equivalent

510(k) numberK974442

Submission

Device name
Pre-Powdered Nitrile Examination Gloves
Applicant
P.T. Latexindo Tobaperkasa
Medan, ID
Received
November 25, 1997
Decision date
January 5, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
LZY – Prosthesis, Hip, Hemi-, Femoral, Metal Ball
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3360
Specialty
Orthopedic
Implant
Yes

Other 510(k)s with product code LZY

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K231448TANDEM Hip SystemLZY · Traditional Smith & Nephew, Inc.07/19/2023SE
K111145Endo HeadLZY · Traditional Medacta International08/16/2011SE
K915528BHR Bipolar Femoral Head ComponentLZY · Traditional Implantology Corp.06/29/1993SE
K915548Ionguard Titanium Modular HeadsLZY · Traditional Biomet, Inc.03/10/1992SE
K903084Modular Cathcart Fracture SystemLZY · Traditional Depuy, Inc.10/03/1990SE
K896580Uni-Polar HeadLZY · Traditional Richards Medical Co., Inc.02/15/1990SE
K892059Femoral Heads/Modular & Fixed W/ Titan Nitride SurLZY · Traditional Protek, Inc.07/19/1989SE

More from Protek, Inc.

510(k)DeviceDecision
K974443Powder Free Nitrile Examination Gloves - Polymer CoatedLYZ · Traditional 01/05/1998SE
K972539Hi Coat Powder Free Latex Patient Examination GlovesLYY · Traditional 11/18/1997SE

Questions and answers

When was Pre-Powdered Nitrile Examination Gloves cleared by the FDA?

Pre-Powdered Nitrile Examination Gloves (K974442) received a 510(k) decision of Substantially Equivalent on January 5, 1998, 41 days after the submission was received.

What is the product code of K974442?

The FDA product code is LZY – Prosthesis, Hip, Hemi-, Femoral, Metal Ball, a Class II (moderate risk) device regulated under 21 CFR 888.3360.