PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves
O&M Halyard, Inc. · General Hospital
Open FDA's page for this record- Third party flag
- N
- City
- Alpharetta
- Advisory committee description
- General Hospital
- Address 1
- 1220 Old Alpharetta Rd.
- Address 2
- Suite 320
- Statement or summary
- Summary
- Product code
- LZA
- Zip code
- 30005
- Applicant
- O&M Halyard, Inc.
- Decision date
- 2026-07-21
- Decision code
- SESE
- Country code
- US
- Device name
- PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves
- Advisory committee
- HO
- Contact
- Sahrudin Shah
- K number
- K262014
- State
- GA
- Date received
- 2026-06-15
- Review advisory committee
- HO
- Postal code
- 30005
- Decision description
- Substantially Equivalent
- Clearance type
- Special
- Harmonized identifiers (openFDA)
- Device name
- Polymer Patient Examination Glove
- Medical specialty description
- General Hospital
- Regulation number
- 880.6250
- Device class
- 1
- Registration number
- 3015335977, 3006157842, 3007707004, 1250045, 3004111573, 3005024094, 3026263452, 3009549523, 1058397, 3022543478, 3017509841, 3031288561, 3013998568, 3022538552, 3009055041, 3013565389, 3015384427, 3015727296, 1319302, 3003887292, 3032579548, 3011200663, 3007842555, 1222115, 3007220726, 3031590640, 9680710, 3005568780, 3038277359, 3021015522, 3017616393, 3010763223, 3030455652, 3011391433, 1420054, 2648727, 3009784353, 1055236, 1025972, 3008058446 +350 more
- FEI number
- 3015335977, 3006157842, 3010862763, 3007707004, 1250045, 3004111573, 3005024094, 3026263452, 3008875470, 3009549523, 1000137528, 1030186, 3022543478, 1000112877, 3017509841, 3031288561, 3004360380, 3013998568, 3003564842, 3022538552, 3009055041, 3013565389, 3015384427, 3015727296, 1319302, 3003887292, 1833338, 3032579548, 3011200663, 3007842555, 3003158169, 1222115, 3007220726, 3031590640, 3038277359, 3021015522, 3003792528, 3017616393, 3010763223, 3030455652 +350 more