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FDA 510(k)

TRI-CLEAN 110/TRI-CLEAN PLUS GLOVE

K-Number: K960590 · 1996-10-31

ApplicantAladan Corp.
Decision Date1996-10-31
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TRI-CLEAN 110/TRI-CLEAN PLUS GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Aladan Corp.. It received FDA 510(k) clearance on 1996-10-31 under 510(k) number K960590. 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 TRI-CLEAN 110/TRI-CLEAN PLUS GLOVE?

TRI-CLEAN 110/TRI-CLEAN PLUS GLOVE is a medical device that received FDA 510(k) clearance on 1996-10-31. The listed applicant is Aladan Corp.. The 510(k) number is K960590.

When did TRI-CLEAN 110/TRI-CLEAN PLUS GLOVE receive FDA 510(k) clearance?

TRI-CLEAN 110/TRI-CLEAN PLUS GLOVE received FDA 510(k) clearance on 1996-10-31, under 510(k) number K960590.

Who is the listed applicant for TRI-CLEAN 110/TRI-CLEAN PLUS GLOVE?

The FDA 510(k) record lists Aladan Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRI-CLEAN 110/TRI-CLEAN PLUS GLOVE?

The FDA product code for TRI-CLEAN 110/TRI-CLEAN PLUS GLOVE is LYY.

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Related Devices (Code: LYY)

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.

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 LimitedK230573Powder 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 BhdK223298Sterile 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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