Pristeen（乳胶外科医生手套无粉，蛋白质含量标签声明为每只手套50ug/dm2或更少的可提取物蛋白）
K号: K172942 · 2018-01-08
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器械摘要
常见问题
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.
相关临床试验
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相关器械（代码：KGO）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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