PATIENT EXAMINATION GLOVES (LATEX)— 510(k) K891821
Substantially EquivalentKoon Seng Sdn Bhd
FDA 510(k) clearance K891821 for PATIENT EXAMINATION GLOVES (LATEX), Substantially Equivalent on 1989-05-31. Applicant: Koon Seng Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Koon Seng Sdn Bhd
- 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
- 81707 Pasir Gudan, Johor, MY
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 Koon Seng Sdn Bhd
view all- K212613 — Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue)
- K171171 — KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black)
- K110960 — ROYAL IMPERIAL NITRILE EXAMINATION GLOVES TEXTURED POWDER-FREE
- K093375 — KS-CARE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50UG OR LESS)
- K013537 — ROYAL IMPERIAL POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
Data sourced from openFDA. This site is unofficial and independent of the FDA.