FDA applicant

Professional Latex Sdn Bhd

Kamunting, MY3 decisions2017–20230 recalls

FDA records 3 decisions for Professional Latex Sdn Bhd (Kamunting, MY) from 2017 to 2023: 3 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and LYY (Latex Patient Examination Glove). Its devices cite 3 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 Professional Latex Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2017high 1 (2017) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Professional Latex Sdn Bhd by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Other applicant names beginning “Professional”

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

Professional Medical Services 19 Professional Medical Products, Inc. 9 Professional Instruments Co. 3 Professional Positioners, Inc. 3 Professional Tape Co., Inc. 2 Professional Services For Surgeons, Ltd. 2 Professional Dental Mfg., Inc. 2 Professional Technologies Corp. 2 Professional Supplies, Inc. 2 Professional Disposables International, Inc. 1 Professional Medical Systems 1 Professional Pharmacy West, Inc. 1

Professional Latex Sdn Bhd

Which product codes does it file in?

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 “Professional”