LATEX EXAMINATION GLOVES, POWDER FREE, POLYMER COATED— 510(k) K021412
Substantially EquivalentArista Latindo Industrial Ltd. P.T
FDA 510(k) clearance K021412 for LATEX EXAMINATION GLOVES, POWDER FREE, POLYMER COATED, Substantially Equivalent on 2002-06-07. Applicant: Arista Latindo Industrial Ltd. P.T. Device class: 1.
Clearance details
- Applicant
- Arista Latindo Industrial Ltd. P.T
- Product code
- Code LYY
- Device class
- Class 1
- Regulation
- 21 CFR 880.6250
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jakarta Barat, ID
Recent devices under product code LYY
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- 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)
- K223298 — Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)
- K222612 — Powder-Free Latex examination gloves
More clearances from Arista Latindo Industrial Ltd. P.T
view all- K041745 — VINYL EXAMINATION GLOVES, POWDER FREE, GREEN COLOR
- K031944 — VINYL EXAMINATION GLOVES, POWDER FREE AND PINK COLOR
- K031913 — VINYL EXAMINATION GLOVES, POWDER FREE, VIOLET COLOR
- K030245 — NITRILE EXAMINATION GLOVES, POWDER FREE, POLYMER COATED, PURPLE COLOR
- K023753 — VINYL EXAMINATION GLOVES, PRE-POWDERED WITH VITAMIN E
Data sourced from openFDA. This site is unofficial and independent of the FDA.