Contents of Examination & Surgical Gloves 510(k) Notification
Required contents of an FDA 510(k) notification for latex and nitrile examination and surgical gloves. LMG prepares complete 510(k) submissions.
510(k) SubmissionExamination GlovesSurgical GlovesSince 2009LMG
An FDA 510(k) premarket notification for examination and surgical gloves must contain the following sections:
- Device description — material, dimensions, construction, intended use (examination vs. surgical)
- Predicate device comparison — substantial equivalence comparison with cleared predicate glove
- Biocompatibility data (ISO 10993) — cytotoxicity, sensitization, irritation, systemic toxicity
- Performance testing — dimensional testing (ASTM D3578/D6319), water leak testing (ASTM D5151).
- Protein content testing (for latex gloves) — ASTM D5712
- Accelerated aging or real time shelf life studies
- Draft labeling — compliant with 21 CFR Part 801 and UDI requirements
- 510(k) summary
LMG prepares complete 510(k) submissions in eSTAR format for examination and surgical glove manufacturers worldwide.
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Device Services
- Medical Device Establishment Registration
- Premarket Notification 510(k)
- FDA Registration for Latex Nitrile Gloves
- Tests Required for Examination Surgical Gloves
- FDA Labeling Requirements for Examination Surgical Gloves
- Biocompatibility Tests for Examination Surgical Gloves
- FDA Registration for Surgical Face Masks
- FDA Premarket Approval PMA
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