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FDA 510(k)

SHARK GLOVES 藍色尼龍檢查手套 無粉，INCONGLOVE 藍色尼龍檢查手套 無粉

K 號：K212308 · 2021-10-29

申請人Srirungruang Global Co., Ltd.
決定日期2021-10-29
產品代碼LZA
諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。
決定相當於

器材摘要

SHARK GLOVES Blue Nitrile Examination Gloves Powder Free, INCONGLOVE Blue Nitrile Examination Gloves Powder Free is the device name listed in this FDA 510(k) record. The listed applicant is Srirungruang Global Co., Ltd.. It received FDA 510(k) clearance on 2021-10-29 under 510(k) number K212308. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SHARK GLOVES Blue Nitrile Examination Gloves Powder Free, INCONGLOVE Blue Nitrile Examination Gloves Powder Free?

SHARK GLOVES Blue Nitrile Examination Gloves Powder Free, INCONGLOVE Blue Nitrile Examination Gloves Powder Free is a medical device that received FDA 510(k) clearance on 2021-10-29. The listed applicant is Srirungruang Global Co., Ltd.. The 510(k) number is K212308.

When did SHARK GLOVES Blue Nitrile Examination Gloves Powder Free, INCONGLOVE Blue Nitrile Examination Gloves Powder Free receive FDA 510(k) clearance?

SHARK GLOVES Blue Nitrile Examination Gloves Powder Free, INCONGLOVE Blue Nitrile Examination Gloves Powder Free received FDA 510(k) clearance on 2021-10-29, under 510(k) number K212308.

Who is the listed applicant for SHARK GLOVES Blue Nitrile Examination Gloves Powder Free, INCONGLOVE Blue Nitrile Examination Gloves Powder Free?

The FDA 510(k) record lists Srirungruang Global Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SHARK GLOVES Blue Nitrile Examination Gloves Powder Free, INCONGLOVE Blue Nitrile Examination Gloves Powder Free?

The FDA product code for SHARK GLOVES Blue Nitrile Examination Gloves Powder Free, INCONGLOVE Blue Nitrile Examination Gloves Powder Free is LZA.

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相關器械（代碼：LZA）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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