The following data is part of a premarket notification filed by Guardian Group, Inc. with the FDA for Guardian Ii Glove.
| Device ID | K945577 |
| 510k Number | K945577 |
| Device Name: | GUARDIAN II GLOVE |
| Classification | Patient Examination Glove, Specialty |
| Applicant | GUARDIAN GROUP, INC. 7770 REGENTS RD., #539 San Diego, CA 92122 |
| Contact | Ron Melton |
| Correspondent | Ron Melton GUARDIAN GROUP, INC. 7770 REGENTS RD., #539 San Diego, CA 92122 |
| Product Code | LZC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-14 |
| Decision Date | 1994-12-29 |