STERILE LATEX POWDERED PATIENT EXAMINATION GLOVES— 510(k) K000891
Substantially EquivalentFitco Dipped Products Pvt., Ltd.
FDA 510(k) clearance K000891 for STERILE LATEX POWDERED PATIENT EXAMINATION GLOVES, Substantially Equivalent on 2000-04-28. Applicant: Fitco Dipped Products Pvt., Ltd.. Device class: 1.
Clearance details
- Applicant
- Fitco Dipped Products Pvt., Ltd.
- 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
- Kerala, IN
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 Fitco Dipped Products Pvt., Ltd.
view all- K001715 — POWDERED PATIENT EXAMINATION GLOVES, LATEX
- K001232 — NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM 50 MICROGRAMS OR LESS
- K000896 — POWDERFREE LATEX SURGEON'S GLOVES WITH PROTIEN LABELING CLAIM (50 MOCROGRAMS OR LESS
- K001216 — POWDER-FREE LATEX EXAMINATION GLOVE STERILE WITH OPTIONAL PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
- K993450 — LATEX SURGICAL GLOVES, PRE-POWDERED
Data sourced from openFDA. This site is unofficial and independent of the FDA.