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FDA 510(k)

Pristeen（乳膠外科醫用手套，無粉，蛋白質含量標示為每副手套50ug/dm2或以下的可提取蛋白質塗層聚合物）

K 號：K172942 · 2018-01-08

申請人Beta Healthcare Products Pvt., Ltd.
決定日期2018-01-08
產品代碼KGO
諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。
決定相當於

器材摘要

Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable protein is the device name listed in this FDA 510(k) record. The listed applicant is Beta Healthcare Products Pvt., Ltd.. It received FDA 510(k) clearance on 2018-01-08 under 510(k) number K172942. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable protein?

Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable protein is a medical device that received FDA 510(k) clearance on 2018-01-08. The listed applicant is Beta Healthcare Products Pvt., Ltd.. The 510(k) number is K172942.

When did Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable protein receive FDA 510(k) clearance?

Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable protein received FDA 510(k) clearance on 2018-01-08, under 510(k) number K172942.

Who is the listed applicant for Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable protein?

The FDA 510(k) record lists Beta Healthcare Products Pvt., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable protein?

The FDA product code for Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable protein is KGO.

相關臨床試驗

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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相關器械（代碼：KGO）

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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