The following data is part of a premarket notification filed by Macro Rubber Industrial, Inc. with the FDA for Skingard Tpf/aosstex Tpf/sensifree/essential Tpf/ameriglo Tpf Latex Examination Gloves.
| Device ID | K973615 |
| 510k Number | K973615 |
| Device Name: | SKINGARD TPF/AOSSTEX TPF/SENSIFREE/ESSENTIAL TPF/AMERIGLO TPF LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | MACRO RUBBER INDUSTRIAL, INC. 3234 ELLA LN. New Port Richey, FL 34655 |
| Contact | Ed Ransom |
| Correspondent | Ed Ransom MACRO RUBBER INDUSTRIAL, INC. 3234 ELLA LN. New Port Richey, FL 34655 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-23 |
| Decision Date | 1998-05-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09551023920147 | K973615 | 000 |
| 09551023920062 | K973615 | 000 |
| 09551023920079 | K973615 | 000 |
| 09551023920086 | K973615 | 000 |
| 09551023920093 | K973615 | 000 |
| 09551023920109 | K973615 | 000 |
| 09551023920116 | K973615 | 000 |
| 09551023920123 | K973615 | 000 |
| 09551023920130 | K973615 | 000 |
| 09551023920055 | K973615 | 000 |