FDA-approved protective case

FDA-approved protective case: Overview

FDA-approved protective cases (Food and Drug Administration) for medical devices and pharma logistics. Materials FDA-compliant per 21 CFR 177.1520 (PP), 21 CFR 177.1580 (PC), 21 CFR 177.1640 (PS). USP Class VI biocompatibility optional (USD 500-1,200 per SKU test). ISO 13485 certified production. Cleanroom final assembly Class 8 (ISO 14644-1, formerly 100,000) available (+USD 1.50/box packaging). IQ/OQ/PQ validation documentation for FDA submission. ETO sterilization compatible (ethylene oxide 100% material compatible). FDA Master File Access Letter for FDA-registered customers. Applications: mobile X-ray, defibrillators, hemodialysis, infusion pumps.

Specifications

Material	PP / ABS / PC / Aluminum
Lead time	30–45 days
Minimum order quantity	500 pieces
Origin	Guangdong, China
Certificates	CE / RoHS / REACH / ISO 9001 / BSCI

Features

• IP67/IP68 waterproof and dustproof (optional IP68 to 5 m depth)
• MIL-STD-810H drop and shock resistance, 26+ drops from 1.2 m
• Custom CNC-cut foam insert tailored to your device
• Pantone-matched colour from 500-piece MOQ
• TSA lock, pressure-equalization valve, O-ring seal
• EXW Guangdong factory or FOB Shenzhen / Ningbo, 30–45 day lead time

Applications

The FDA-approved protective case is used across many industries: industrial, photography, drone, defense, medical, rescue, radio, surveying, marine and more. OEM/ODM customization is standard.