FDA 510(k)

SOUTHLAND POWDERFREE (POLYMER-COATED) LATEX EXAMINATION GLOVES

K-Number: K990751 · 1999-03-23

Decision Date1999-03-23

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SOUTHLAND POWDERFREE (POLYMER-COATED) LATEX EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Southland Products Co., Ltd.. It received FDA 510(k) clearance on 1999-03-23 under 510(k) number K990751. 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 SOUTHLAND POWDERFREE (POLYMER-COATED) LATEX EXAMINATION GLOVES?

SOUTHLAND POWDERFREE (POLYMER-COATED) LATEX EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 1999-03-23. The listed applicant is Southland Products Co., Ltd.. The 510(k) number is K990751.

When did SOUTHLAND POWDERFREE (POLYMER-COATED) LATEX EXAMINATION GLOVES receive FDA 510(k) clearance?

SOUTHLAND POWDERFREE (POLYMER-COATED) LATEX EXAMINATION GLOVES received FDA 510(k) clearance on 1999-03-23, under 510(k) number K990751.

Who is the listed applicant for SOUTHLAND POWDERFREE (POLYMER-COATED) LATEX EXAMINATION GLOVES?

The FDA 510(k) record lists Southland Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOUTHLAND POWDERFREE (POLYMER-COATED) LATEX EXAMINATION GLOVES?

The FDA product code for SOUTHLAND POWDERFREE (POLYMER-COATED) LATEX EXAMINATION GLOVES is LYY.

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Other records listing Southland Products Co., Ltd. as applicant

K990746SOUTHLAND POWDERFREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM K901903PATIENT EXAMINATION GLOVES

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

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