POWDERED NATURAL AND/OR COLORED LATEX EXAM GLOVES— 510(k) K023590

Clearance details

Applicant

Yty Industry (Manjung) Sdn Bhd

Product code

Code LYY

Device class

Class 1

Regulation

21 CFR 880.6250

Advisory panel

General Hospital

Date received

2002-10-25

Decision date

2002-11-08

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Sparks, NV, US

• K250069 — Powder Free Natural Rubber Latex Examination Gloves Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein2025-04-29
• K240266 — Latex Examination Glove Powder Free (Ocean Blue and Natural White)2024-09-09
• K230573 — Powder 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)2023-06-13
• K223298 — Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)2023-02-22
• K222612 — Powder-Free Latex examination gloves2022-11-25

• K220644 — Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use, Doffy® Nitrile Examination Glove, Tested for use with Chemotherapy Drugs2023-03-25
• K202536 — Non-sterile, Powder Free Nitrile Examination Aloe Vera Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, And Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate2021-08-11
• K200453 — NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, AND TESTED FOR USE WITH CHEMOTHERAPY DRUGS BLUE-AC2020-05-01
• K182383 — Non-Sterile, PF Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs-Blue2019-03-19
• K171104 — Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Blue, Cobalt Blue)2017-08-25