POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)— 510(k) K982897
Substantially EquivalentPt. Maja Agung Latexindo
FDA 510(k) clearance K982897 for POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS), Substantially Equivalent on 1998-12-23. Applicant: Pt. Maja Agung Latexindo. Device class: 1.
Clearance details
- Applicant
- Pt. Maja Agung Latexindo
- 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
- Baldwin Park, CA, US
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 Pt. Maja Agung Latexindo
view all- K212408 — Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid)
- K161099 — Powder Free Nitrile Examination Gloves, Black
- K081488 — POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE
- K062709 — POWDER FREE LATEX EXAMINATION GLOVES, BLACK
- K020040 — LATEX PRE-POWDERED EXAMINATION GLOVES WITH PROTEIN CLAIM
Data sourced from openFDA. This site is unofficial and independent of the FDA.