GCI Sterilization Wrappers

GCI Sterilization Wrappers are textile-based wraps designed to enclose reusable medical devices such as surgical gowns, towels, and drapes for steam sterilization. They maintain sterility of enclosed items for up to 28 days and are reusable through 38 wash, dry, and sterilization cycles. Available in seven sizes from 18×18 inches to 60×60 inches, each with color-coded borders and validated load limits.

The subject device is a 99% polyester, 1% carbon woven wrap with cut-and-sew construction, validated for prevacuum steam sterilization at 132°C for 4 minutes with 30-minute dry time. It differs from the predicate in use life (38 vs. 75 cycles), color options (multiple edging colors vs. three solid colors), and maximum validated load weight (25 lbs vs. 12.9 lbs). Both are non-sterile, reusable physical barriers processed via steam sterilization.

Testing conducted per ASTM D5587 (tear strength), ASTM D5034 (breaking strength), 16 CFR 1610 (flammability), AATCC 127 (hydrostatic pressure), AATCC 42 (impact penetration), ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization), AAMI TIR12/TIR30 (reprocessing effectiveness), and ANSI/AAMI/ISO 17665-1 (sterilization validation). All tests passed pre-determined acceptance criteria.

The subject device is substantially equivalent because it shares the same intended use, method of action (physical barrier), regulatory classification (Class II, Product Code FRG), materials composition (polyester-based woven fabric), and sterilization principle (prevacuum steam at similar temperature/time). Performance testing demonstrates non-inferiority or superiority in all key attributes (tear strength, breaking strength, water resistance, linting, cytotoxicity, sterilization validation). Minor differences in reuse cycles and color options are not relevant to safety or effectiveness; differences were assessed against relevant standards and met acceptance criteria.