SURGEON'S GLOVES PRE-POWDERED, MODELS 6.5, 7, 7.5, 8, 8.5— 510(k) K992752
Substantially EquivalentPt. Maja Agung Latexindo
FDA 510(k) clearance K992752 for SURGEON'S GLOVES PRE-POWDERED, MODELS 6.5, 7, 7.5, 8, 8.5, Substantially Equivalent on 1999-11-05. Applicant: Pt. Maja Agung Latexindo. Device class: 1.
Clearance details
- Applicant
- Pt. Maja Agung Latexindo
- Product code
- Code KGO
- Device class
- Class 1
- Regulation
- 21 CFR 878.4460
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- City Of Industry, CA, US
Recent devices under product code KGO
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- K240790 — Polyisoprene Surgical gloves
- K232079 — Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green) +1 more
More clearances from Pt. Maja Agung Latexindo
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- 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.