FDA 510(k)

LATEX POWDERFREE STERILE EXAMINATION GLOVES, MODELS-EXTRA SMALL, SMALL, MEDIUM, LARGE, EXTRA LARGE

K-Number: K013996 · 2002-02-26

Decision Date2002-02-26

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

LATEX POWDERFREE STERILE EXAMINATION GLOVES, MODELS-EXTRA SMALL, SMALL, MEDIUM, LARGE, EXTRA LARGE is the device name listed in this FDA 510(k) record. The listed applicant is Pt. Maja Agung Latexindo. It received FDA 510(k) clearance on 2002-02-26 under 510(k) number K013996. 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 POWDERFREE STERILE EXAMINATION GLOVES, MODELS-EXTRA SMALL, SMALL, MEDIUM, LARGE, EXTRA LARGE?

LATEX POWDERFREE STERILE EXAMINATION GLOVES, MODELS-EXTRA SMALL, SMALL, MEDIUM, LARGE, EXTRA LARGE is a medical device that received FDA 510(k) clearance on 2002-02-26. The listed applicant is Pt. Maja Agung Latexindo. The 510(k) number is K013996.

When did LATEX POWDERFREE STERILE EXAMINATION GLOVES, MODELS-EXTRA SMALL, SMALL, MEDIUM, LARGE, EXTRA LARGE receive FDA 510(k) clearance?

LATEX POWDERFREE STERILE EXAMINATION GLOVES, MODELS-EXTRA SMALL, SMALL, MEDIUM, LARGE, EXTRA LARGE received FDA 510(k) clearance on 2002-02-26, under 510(k) number K013996.

Who is the listed applicant for LATEX POWDERFREE STERILE EXAMINATION GLOVES, MODELS-EXTRA SMALL, SMALL, MEDIUM, LARGE, EXTRA LARGE?

The FDA 510(k) record lists Pt. Maja Agung Latexindo as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LATEX POWDERFREE STERILE EXAMINATION GLOVES, MODELS-EXTRA SMALL, SMALL, MEDIUM, LARGE, EXTRA LARGE?

The FDA product code for LATEX POWDERFREE STERILE EXAMINATION GLOVES, MODELS-EXTRA SMALL, SMALL, MEDIUM, LARGE, EXTRA LARGE 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 Pt. Maja Agung Latexindo as applicant

K212408Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid)K161099Powder Free Nitrile Examination Gloves, Black K081488POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE K062709POWDER FREE LATEX EXAMINATION GLOVES, BLACK K020040LATEX PRE-POWDERED EXAMINATION GLOVES WITH PROTEIN CLAIM K001274LATEX SURGEON SURGEON'S GLOVES POWDER-FREE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

View all 11 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.