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FDA 510(k)

Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric Acid

K番号: K260312 · 2026-09-08

申請者Gmp Medicare Sdn. Bhd.
決定日2026-09-08
製品コードLZA
諮問委員会HO
決定Substantially Equivalent

医療機器の概要

Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric Acid is the device name listed in this FDA 510(k) record. The listed applicant is Gmp Medicare Sdn. Bhd.. It received FDA 510(k) clearance on 2026-09-08 under 510(k) number K260312. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric Acid?

Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric Acid is a medical device that received FDA 510(k) clearance on 2026-09-08. The listed applicant is Gmp Medicare Sdn. Bhd.. The 510(k) number is K260312.

When did Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric Acid receive FDA 510(k) clearance?

Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric Acid received FDA 510(k) clearance on 2026-09-08, under 510(k) number K260312.

Who is the listed applicant for Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric Acid?

The FDA 510(k) record lists Gmp Medicare Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric Acid?

The FDA product code for Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric Acid is LZA.

関連する臨床試験

関連レコードは、名称、製品コード、その他のメタデータを使用して自動的にマッチングされます。マッチは検証された臨床的、科学的、企業的、または規制上の関係を確立するものではありません。リンクされた公式情報源をご確認ください。

NCT07608549FLASH試験フェーズ1安全性研究NOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751膀胱癌を診断するための人工知能（AI）アシストドのUro-Camカテーテル評価システムNOT_YET_RECRUITING

申請者としてGmp Medicare Sdn. Bhd.を記載するその他の記録

関連レコードは、名称、製品コード、その他のメタデータを使用して自動的にマッチングされます。マッチは検証された臨床的、科学的、企業的、または規制上の関係を確立するものではありません。リンクされた公式情報源をご確認ください。

K250944Nitrile Powder Free Examination Glove, Blue Tested for Use with 60 Chemotherapy Drugs, Gastric Acid, Xylazine and FentanylK202003Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance ClaimK163017Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs

関連機器（コード：LZA）

関連レコードは、名称、製品コード、その他のメタデータを使用して自動的にマッチングされます。マッチは検証された臨床的、科学的、企業的、または規制上の関係を確立するものではありません。リンクされた公式情報源をご確認ください。

K261793Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)Maxter Healthcare, Inc.K262542バイオデグレードブルー・ニトリル・パウダーフリー・検査手袋、緑色；バイオデグレードブルー・ニトリル・パウダーフリー・検査手袋、紫青色；32種類の化学療法薬、フェンタニルおよび胃酸透過抵抗性を検証済みTop Glove Sdn. Bhd.K261749カーディナルヘルス ニトリルブルー検査手袋 が化学療法薬およびフェンタニルシチル酸との使用を検証済みCardinalhealthK260794NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLORKossan International Sdn BhdK262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.K254285Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Violet BlueHartalega NGC Sdn. Bhd.

公式ソース

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データはFDA Open APIから取得しています。最新かつ権威ある情報については、常に公式レコードを参照してください。

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