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FDA 510(k)

POWDER-FREE NITRILE EXAMINATION GLOVE (BLUE) WITH NATURAL WATER SOLUBLE VITAMIN E AND ALOE VERA, PEPPERMINT SCENTED

K-Number: K031157 · 2003-08-15

ApplicantQingdao Bestex Rubber & Plastic Products Co., Ltd.
Decision Date2003-08-15
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

POWDER-FREE NITRILE EXAMINATION GLOVE (BLUE) WITH NATURAL WATER SOLUBLE VITAMIN E AND ALOE VERA, PEPPERMINT SCENTED is the device name listed in this FDA 510(k) record. The listed applicant is Qingdao Bestex Rubber & Plastic Products Co., Ltd.. It received FDA 510(k) clearance on 2003-08-15 under 510(k) number K031157. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POWDER-FREE NITRILE EXAMINATION GLOVE (BLUE) WITH NATURAL WATER SOLUBLE VITAMIN E AND ALOE VERA, PEPPERMINT SCENTED?

POWDER-FREE NITRILE EXAMINATION GLOVE (BLUE) WITH NATURAL WATER SOLUBLE VITAMIN E AND ALOE VERA, PEPPERMINT SCENTED is a medical device that received FDA 510(k) clearance on 2003-08-15. The listed applicant is Qingdao Bestex Rubber & Plastic Products Co., Ltd.. The 510(k) number is K031157.

When did POWDER-FREE NITRILE EXAMINATION GLOVE (BLUE) WITH NATURAL WATER SOLUBLE VITAMIN E AND ALOE VERA, PEPPERMINT SCENTED receive FDA 510(k) clearance?

POWDER-FREE NITRILE EXAMINATION GLOVE (BLUE) WITH NATURAL WATER SOLUBLE VITAMIN E AND ALOE VERA, PEPPERMINT SCENTED received FDA 510(k) clearance on 2003-08-15, under 510(k) number K031157.

Who is the listed applicant for POWDER-FREE NITRILE EXAMINATION GLOVE (BLUE) WITH NATURAL WATER SOLUBLE VITAMIN E AND ALOE VERA, PEPPERMINT SCENTED?

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

What is the FDA product code for POWDER-FREE NITRILE EXAMINATION GLOVE (BLUE) WITH NATURAL WATER SOLUBLE VITAMIN E AND ALOE VERA, PEPPERMINT SCENTED?

The FDA product code for POWDER-FREE NITRILE EXAMINATION GLOVE (BLUE) WITH NATURAL WATER SOLUBLE VITAMIN E AND ALOE VERA, PEPPERMINT SCENTED is LZA.

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Other records listing Qingdao Bestex Rubber & Plastic Products Co., Ltd. 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.

K220597Disposable Surgical Face Mask (FM-34EE,FM-44EE)K042645POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA, NATURAL WATER, SOLUBLE VITAMIN E AND VITAMIN C AND PROTEIN LABELINGK022566POWDER-FREE LATEX EXAMINATION GLOVE (GREEN) WITH NATURAL WATER SOLUBLE VITAMIN E AND PROTEIN CONTENT LABELING (50 MICROK012709POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (GREEN)K002087BESTEX POWDER-FREE LATEX EXAM GLOVES WITH LABELING CLAIM. (50 MICROGRAMS OR LESS)

Related Devices (Code: LZA)

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.

K261793Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)Maxter Healthcare, Inc.K262542Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance ClaimTop Glove Sdn. Bhd.K260312Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric AcidGmp Medicare Sdn. Bhd.K261749Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl CitrateCardinalhealthK260794NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLORKossan International Sdn BhdK262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.

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.

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