FDA applicant

Blue Sail Medical Co.,Ltd

Zibo, CN2 decisions2017–20170 recalls

FDA records 2 decisions for Blue Sail Medical Co.,Ltd (Zibo, CN) in 2017: 2 510(k) clearances. All are in product code LZA (Polymer Patient Examination Glove). 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 Blue Sail Medical Co.,Ltd’s devices, and how often a recall has named them.

FDA decisions per year

2in 2017

2017high 2 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Blue Sail Medical Co.,Ltd by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Blue”

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

Blue Belt Technologies, Inc. 22 Blue Sky Bio, LLC 21 Blue Ridge Media Co. 11 Blue Ortho 9 Blue Sky Medical Group Incorporated 4 Blue Planet Industries, Inc. 3 Blue Torch Medical Technologies 2 Blue X Imaging Srl 2 Blue Spark Technologies, Inc. 2 Blue & Red Corp. 1 Blue Focus 1 Blue Gem Sunglasses, Inc. 1

Blue Sail Medical Co.,Ltd

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Blue”