FDA 510(k)

ROYAL SHIELD NON-STERILE LATEX EXAMINATION GLOVES

K-Number: K952588 · 1995-10-12

ApplicantShield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc.

Decision Date1995-10-12

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

ROYAL SHIELD NON-STERILE LATEX EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc.. It received FDA 510(k) clearance on 1995-10-12 under 510(k) number K952588. 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 ROYAL SHIELD NON-STERILE LATEX EXAMINATION GLOVES?

ROYAL SHIELD NON-STERILE LATEX EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 1995-10-12. The listed applicant is Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc.. The 510(k) number is K952588.

When did ROYAL SHIELD NON-STERILE LATEX EXAMINATION GLOVES receive FDA 510(k) clearance?

ROYAL SHIELD NON-STERILE LATEX EXAMINATION GLOVES received FDA 510(k) clearance on 1995-10-12, under 510(k) number K952588.

Who is the listed applicant for ROYAL SHIELD NON-STERILE LATEX EXAMINATION GLOVES?

The FDA 510(k) record lists Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROYAL SHIELD NON-STERILE LATEX EXAMINATION GLOVES?

The FDA product code for ROYAL SHIELD NON-STERILE LATEX EXAMINATION GLOVES is LYY.

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Other records listing Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc. as applicant

K952590ROYAL SHIELD NON-STERILE PINK COLOERED, STRAWBERRY SCENTED LATEX EXAMINATION GLOVES K952591ROYAL SHIELD NON-STERILE BLUE COLORED BUBBLE GUM SCENTED LATEX EXAMINATION GLOVES K926132ROYAL SHIELD SHIELD GLOVES K890907ROYAL SHIELD LATEX EXAMINATION GLOVES(TM)

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.