Full Scale Development and Initial Production of the Personnel/Casualty Decontamination System Skin Decontamination Kit (PCDS SDK)
Abstract
Under this contract, designated Full Scale Development and Initial Production of the Personnel/Casualty Decontamination System Skin Decontamination Kit (PCDS SDK) , the Rohm and Haas Company and its subcontractor, PACO pharmaceutical Services Inc. focused upon improving the operational deficiencies inherent to the Prototype design skin decontamination system developed under a previous contract. In order to support the new designs, Level I drawings and specifications were prepared for the applicators, packets, soft pack pouch assemblies and also the unit of issue (box of 20 decontaminating kits). Procurement of materials, manufacturing process development and obtaining equipment/tooling were accomplished prior to kit manufacture. The FDA has determined the Personnel/Casualty Decontamination System - Skin Decontamination Kit (PCDS-SDK), ultimately type classified as the Decontaminating Kit, Skin: M291, to be a medical device and subject to FDA regulation as such.
Document Details
- Document Type
- Technical Report
- Publication Date
- Nov 01, 1991
- Accession Number
- ADA244438
Entities
People
- Noah Borenstein