FDA applicant

Showa Best Glove, Inc.

Menlo, GA4 decisions2018–20220 recalls

FDA records 4 decisions for Showa Best Glove, Inc. (Menlo, GA) from 2018 to 2022: 4 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and LZC (Medical Glove, Specialty). Since 2016 its 510(k)s took a median of 231 days from receipt to decision, against 178 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Showa Best Glove, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2018high 2 (2018) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Showa Best Glove, Inc. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Showa Best Glove, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Showa”

FDA records each applicant name separately; these may or may not be the same firm.

Showa Ika Kohgyo Co., Ltd. 2 Showa Engineering Co., Ltd. 1 Showa X-Ray Co., Ltd. 1

Showa Best Glove, Inc.

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Showa”