FDA 510(k)

LATEX PATIENT EXAMINATION GLOVES POWDERED WITH PROTEIN CONTENT LABELING CLAIM; 100 MICROGRAM OR LESS OF TOTAL WATER EXTR

K-Number: K002314 · 2000-08-17

ApplicantPerusahaan Getah Asas Sdn. Bhd.

Decision Date2000-08-17

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

LATEX PATIENT EXAMINATION GLOVES POWDERED WITH PROTEIN CONTENT LABELING CLAIM; 100 MICROGRAM OR LESS OF TOTAL WATER EXTR is the device name listed in this FDA 510(k) record. The listed applicant is Perusahaan Getah Asas Sdn. Bhd.. It received FDA 510(k) clearance on 2000-08-17 under 510(k) number K002314. 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 LATEX PATIENT EXAMINATION GLOVES POWDERED WITH PROTEIN CONTENT LABELING CLAIM; 100 MICROGRAM OR LESS OF TOTAL WATER EXTR?

LATEX PATIENT EXAMINATION GLOVES POWDERED WITH PROTEIN CONTENT LABELING CLAIM; 100 MICROGRAM OR LESS OF TOTAL WATER EXTR is a medical device that received FDA 510(k) clearance on 2000-08-17. The listed applicant is Perusahaan Getah Asas Sdn. Bhd.. The 510(k) number is K002314.

When did LATEX PATIENT EXAMINATION GLOVES POWDERED WITH PROTEIN CONTENT LABELING CLAIM; 100 MICROGRAM OR LESS OF TOTAL WATER EXTR receive FDA 510(k) clearance?

LATEX PATIENT EXAMINATION GLOVES POWDERED WITH PROTEIN CONTENT LABELING CLAIM; 100 MICROGRAM OR LESS OF TOTAL WATER EXTR received FDA 510(k) clearance on 2000-08-17, under 510(k) number K002314.

Who is the listed applicant for LATEX PATIENT EXAMINATION GLOVES POWDERED WITH PROTEIN CONTENT LABELING CLAIM; 100 MICROGRAM OR LESS OF TOTAL WATER EXTR?

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

What is the FDA product code for LATEX PATIENT EXAMINATION GLOVES POWDERED WITH PROTEIN CONTENT LABELING CLAIM; 100 MICROGRAM OR LESS OF TOTAL WATER EXTR?

The FDA product code for LATEX PATIENT EXAMINATION GLOVES POWDERED WITH PROTEIN CONTENT LABELING CLAIM; 100 MICROGRAM OR LESS OF TOTAL WATER EXTR 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 Perusahaan Getah Asas Sdn. Bhd. as applicant

K102790POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUG K042805POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLORED NON-STERILE K032374POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLORED K031625POWDER-FREE BARRIER-PRO CO-POLYMER EXAMINATION GLOVE, WHITE (NON-COLORED), AND GREEN COLORED K031768BARRIER-PRO CO-POLYMER PATIENT EXAMINATION GLOVE, POWDERED, WHITE (NON-COLORED) OR GREEN COLORED K031414POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), OR BLUE COLORED, WITH EXTRACTABLE PROTEIN CONTENT LABE

View all 30 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.