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FDA 510(k)

PERFECT TOUCH PATIENT EXAM GLOVES (LATEX)

K-Number: K891738 · 1989-04-26

ApplicantYoung Innovations, LLC Dba Plak Smacker
Decision Date1989-04-26
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PERFECT TOUCH PATIENT EXAM GLOVES (LATEX) is the device name listed in this FDA 510(k) record. The listed applicant is Young Innovations, LLC Dba Plak Smacker. It received FDA 510(k) clearance on 1989-04-26 under 510(k) number K891738. 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 PERFECT TOUCH PATIENT EXAM GLOVES (LATEX)?

PERFECT TOUCH PATIENT EXAM GLOVES (LATEX) is a medical device that received FDA 510(k) clearance on 1989-04-26. The listed applicant is Young Innovations, LLC Dba Plak Smacker. The 510(k) number is K891738.

When did PERFECT TOUCH PATIENT EXAM GLOVES (LATEX) receive FDA 510(k) clearance?

PERFECT TOUCH PATIENT EXAM GLOVES (LATEX) received FDA 510(k) clearance on 1989-04-26, under 510(k) number K891738.

Who is the listed applicant for PERFECT TOUCH PATIENT EXAM GLOVES (LATEX)?

The FDA 510(k) record lists Young Innovations, LLC Dba Plak Smacker as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PERFECT TOUCH PATIENT EXAM GLOVES (LATEX)?

The FDA product code for PERFECT TOUCH PATIENT EXAM GLOVES (LATEX) is LYY.

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Other records listing Young Innovations, LLC Dba Plak Smacker as applicant

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.

K981600LATEX EXAMINATION GLOVES BUBBLE GUM FLAVOURED PRE-POWDERED

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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