Best Manufacturing Company: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Best Manufacturing Company” (first 1999, latest 2002), across 1 product code in 1 review panel. Median 510(k) review time under this name: 56 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LZA | Polymer Patient Examination Glove | 6 | 6 |
Review panels
- General Hospital (6)
Most recent Best Manufacturing Company 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K022024 | NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (GREEN) | LZA | 2002-08-01 | 42 |
| K012899 | GREEN NITRILE POWDER-FREE MEDICAL EXMAINATION GLOVE | LZA | 2001-09-18 | 20 |
| K012166 | NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (BROWN) | LZA | 2001-08-01 | 21 |
| K001375 | ULTIMATE N-DEX POWER FREE NITRILE EXMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) | LZA | 2000-07-25 | 85 |
| K993805 | NITRI-CARE NITRILE POWDER-FREE STERILE MEDICAL EXAMINATION GLOVES (BLUE, CHERRY FLAVORED) | LZA | 2000-03-10 | 122 |
| K992170 | N-DEX BLUE POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE | LZA | 1999-09-07 | 71 |
Recalls
openFDA lists no recalls under a recalling firm named Best Manufacturing Company.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Best Industries (9 510(k)s)
- Best Medical International, Inc. (6 510(k)s)
- Best Nomos (5 510(k)s)
- Best Labs (4 510(k)s)
- Best Putra Gloves Sdn Bhd (4 510(k)s)
- Best Theratronics Limited (4 510(k)s)
- Best Assoc. Corp. (2 510(k)s)
- Best Glove, Inc. (2 510(k)s)
- Best Sanitizers, Inc. (2 510(k)s)
- Best Aid, Inc. (1 510(k)s)
- Best Care Trading Co., Ltd. (1 510(k)s)
- Best Manufacturing Company-Distribution Center (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Best Manufacturing Company?
FDA lists 6 510(k) clearances under the applicant name “Best Manufacturing Company” (first 1999, latest 2002), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Best Manufacturing Company?
The median time from FDA receipt to decision across 510(k)s cleared under the name Best Manufacturing Company is 56 days.
Which FDA product codes appear under Best Manufacturing Company?
The most frequent FDA product codes under this applicant name are LZA (Polymer Patient Examination Glove, 6).
Next steps
- See all 6 Best Manufacturing Company clearances with predicates and recalls
- Run predicate analysis for product code LZA, Best Manufacturing Company's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.