POWDERED EXAMINATION GLOVES— 510(k) K930995
Substantially EquivalentP.T. Healthcare Glovindo
FDA 510(k) clearance K930995 for POWDERED EXAMINATION GLOVES, Substantially Equivalent on 1993-08-16. Applicant: P.T. Healthcare Glovindo. Device class: 1.
Clearance details
- Applicant
- P.T. Healthcare Glovindo
- 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, ID
Recent devices under product code LYY
view all- K250069 — Powder Free Natural Rubber Latex Examination Gloves Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein
- K240266 — Latex Examination Glove Powder Free (Ocean Blue and Natural White)
- 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 P.T. Healthcare Glovindo
view all- K021659 — PRE-POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (180 UG/OR LESS)
- K010232 — PRE-POWDERED NITRILE EXAMINATION GLOVES
- K010233 — POWDER FREE NITRILE EXAMINATION GLOVES
- K000838 — DIGITCARE POWDER FREE COATED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
- K974853 — LATEX (POWDER FREE) LOW PROTEIN
Data sourced from openFDA. This site is unofficial and independent of the FDA.