FDA 510(k)

PRE-POWDERED LATEX EXAMINATION GLOVE WITH OAT-STARCH POWDER

K-Number: K992117 · 1999-09-27

Decision Date1999-09-27

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

PRE-POWDERED LATEX EXAMINATION GLOVE WITH OAT-STARCH POWDER is the device name listed in this FDA 510(k) record. The listed applicant is Pamitex Industries Sdn Bhd. It received FDA 510(k) clearance on 1999-09-27 under 510(k) number K992117. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRE-POWDERED LATEX EXAMINATION GLOVE WITH OAT-STARCH POWDER?

PRE-POWDERED LATEX EXAMINATION GLOVE WITH OAT-STARCH POWDER is a medical device that received FDA 510(k) clearance on 1999-09-27. The listed applicant is Pamitex Industries Sdn Bhd. The 510(k) number is K992117.

When did PRE-POWDERED LATEX EXAMINATION GLOVE WITH OAT-STARCH POWDER receive FDA 510(k) clearance?

PRE-POWDERED LATEX EXAMINATION GLOVE WITH OAT-STARCH POWDER received FDA 510(k) clearance on 1999-09-27, under 510(k) number K992117.

Who is the listed applicant for PRE-POWDERED LATEX EXAMINATION GLOVE WITH OAT-STARCH POWDER?

The FDA 510(k) record lists Pamitex Industries Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRE-POWDERED LATEX EXAMINATION GLOVE WITH OAT-STARCH POWDER?

The FDA product code for PRE-POWDERED LATEX EXAMINATION GLOVE WITH OAT-STARCH POWDER is LYY.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Pamitex Industries Sdn Bhd as applicant

K003350HEALTH-PLUS, SANITEX, RELIANCE MULTIPLY POWDER FREE POLYMER AND NITRILE COATED (BLUE)K000952HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATION GLOVES - BLUE COLOR K001674POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR K001672POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVES K993756HEALTH-PLUS, SANITEX, RELIANCE STERILE POWDER-FREE NITRILE SURGICAL GLOVES K000828HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LAXTEX EXAMINATION GLOVE

View all 19 devices →

Related Devices (Code: LYY)

K250069Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less ProteinComfort Rubber Gloves Industries Sdn. Bhd.K240266Latex Examination Glove Powder Free (Ocean Blue and Natural White)Sri Trang Gloves (Thailand) Public Company Limited K230573Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)Kossan International Sdn Bhd K223298Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)Shandong Intco Medical Products Co, Ltd.K222612Powder-Free Latex examination glovesGuangdong Kingfa Sci. & Tech.Co., Ltd.K221667Non Sterile Powder Free Latex Examination GloveNew Era Medicare Sdn. Bhd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.