CHALLENGE POWDER-FREE, HYPOALLERGENIC, SYNTHETIC SURGICAL GLOVES
FDA 510(k) clearance K935917 · decided 1994-02-04
Clearance details
- K-number
- K935917
- Device name
- CHALLENGE POWDER-FREE, HYPOALLERGENIC, SYNTHETIC SURGICAL GLOVES
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decision
- Substantially Equivalent
- Date received
- 1993-12-10
- Decision date
- 1994-02-04
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- KGB
- Device class
- 1
- Regulation number
- 868.5570
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Franklin Lakes, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| POCKET RESCUE (K970688) | Cheen Houng Ent. Co. , Ltd. | 1997-09-26 |
| ULTIMATE SEAL (K960401) | Hans Rudolph, Inc. | 1996-06-20 |
| COMBO MASK (K941336) | Gam Industries, Inc. | 1994-09-09 |
| COMPACT MASK (K932347) | Vital Signs, Inc. | 1994-01-10 |
| NONREBREATHING VALVE (K933583) | Hans Rudolph, Inc. | 1994-01-03 |
| LAERDAL(TM) POCKET MASK, MODIFICATION (K933048) | Laerdal Medical Corp. | 1993-12-02 |
| PROFAST(R)-DENTURE ADHESIVE CREAM (K930336) | Fittydent-Altwirth & Schmitt GmbH | 1993-08-24 |
| NON REBREATHING MASK (K913164) | Specialty Packaging Producs, Inc. | 1992-01-15 |
| MOUTH-TO-MASK VENTILATORY ADJUNCT (K883766) | Medic One | 1988-10-21 |
| OXYGEN MASK, CONCENTRATION AEROSOL MASK (K790162) | Airlife, Inc. | 1979-04-20 |
| OXYGEN MASK W/RESERVOIR BAG (K790161) | Airlife, Inc. | 1979-04-20 |
| MASK, OXYGEN, NONBREATHING (K781414) | Vitalab Products Corp. | 1978-09-07 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OXYCELL (N5798/S007) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995-07-24 |
| OXYCEL OXIDIZED (N5798/S005) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-02-08 |
| OXYCELL (N5798/S006) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-02-08 |
| MINI BALLOON (P780011/S012) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-10-30 |
| MINI BALLOON (P780011/S011) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-10-18 |
| MINI BALLOON (P780011/S010) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-01-29 |
| MINI BALLOON (P780011/S007) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-01-23 |
| BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC (P800030/S006) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-11-05 |