FDA 510(k)

HWA TEH EXAMINATION GLOVES

K-Number: K896251 · 1989-11-21

Decision Date1989-11-21

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

HWA TEH EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Hwa Teh Industrial Sdn. Bhd.. It received FDA 510(k) clearance on 1989-11-21 under 510(k) number K896251. 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 HWA TEH EXAMINATION GLOVES?

HWA TEH EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 1989-11-21. The listed applicant is Hwa Teh Industrial Sdn. Bhd.. The 510(k) number is K896251.

When did HWA TEH EXAMINATION GLOVES receive FDA 510(k) clearance?

HWA TEH EXAMINATION GLOVES received FDA 510(k) clearance on 1989-11-21, under 510(k) number K896251.

Who is the listed applicant for HWA TEH EXAMINATION GLOVES?

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

What is the FDA product code for HWA TEH EXAMINATION GLOVES?

The FDA product code for HWA TEH EXAMINATION GLOVES 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 Hwa Teh Industrial Sdn. Bhd. as applicant

K010803POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR K000725HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS)K994432HWA & SILKTEX POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (140 MICROGRAMS OR LESS)K992810HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE K992730HWA (AND) SILKTEX PRE-POWDERED LATEX EXAMINATION GLOVE

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.