FLAVORED LATEX PATIENT EXAMINATION— 510(k) K960315
Substantially EquivalentP.T. Irama Dinamika Latex
FDA 510(k) clearance K960315 for FLAVORED LATEX PATIENT EXAMINATION, Substantially Equivalent on 1996-11-20. Applicant: P.T. Irama Dinamika Latex. Device class: 1.
Clearance details
- Applicant
- P.T. Irama Dinamika Latex
- 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
- Indonesia, 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 P.T. Irama Dinamika Latex
view all- K984449 — NATURAL RUBBER PRE-POWDERED COLORED & FLAVORED PATIENT EXAMINATION GLOVES WITH PROTEIN LABELLING CLAIM
- K981064 — POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES
- K980848 — HYPOALLERGENIC LATEX PATIENT EXAM GLOVES-PREPOWDERED
- K972306 — POWDERFREE COLORED AND FLAVORED NITRILE COPOLYMER PATIENT EXAMINATION GLOVES-MEDICAL DEVICE
- K965155 — LATEX EXAM GLOVES
Data sourced from openFDA. This site is unofficial and independent of the FDA.