Tests Required for Examination & Surgical Gloves
Complete list of tests required for FDA 510(k) clearance of latex and nitrile examination and surgical gloves.
Liberty Management GroupSince 2009
The following tests are required for FDA 510(k) clearance of examination and surgical gloves:
- Biocompatibility testing (ISO 10993) — cytotoxicity, sensitization, intracutaneous reactivity/Test for irritation
- Dimensional testing — length, width, thickness (ASTM D3578/D6319)
- Water leak testing — ASTM D5151Â
- Powder free residue testing-ASTM D6124
- Protein content testing — for latex gloves (ASTM D5712)
- Shelf life testing (real-time and accelerated) – ASTM D7160
- AQL (Acceptable Quality Level) for all tests as per ANSI/ASQ Z1.4
- Packaging validation (ISO 11607) for sterile surgical gloves
LMG assists glove manufacturers with test planning, test report review, and complete 510(k) submission preparation (eSTAR format).
Need FDA 510(k) Consulting?
Contact Liberty Management Group for expert FDA regulatory consulting.
Contact LMGRelated Pages
Device Services
- Medical Device Establishment Registration
- Premarket Notification 510(k)
- FDA Registration for Latex Nitrile Gloves
- FDA Labeling Requirements for Examination Surgical Gloves
- Biocompatibility Tests for Examination Surgical Gloves
- Contents of Examination Surgical Gloves
- FDA Registration for Surgical Face Masks
- FDA Premarket Approval PMA
Supporting Articles