Tyvek® IsoClean® Sterile Hood with Attached Face Mask - GMP C/D

The DuPont™ Tyvek® IsoClean® IC 982 B WH MS is a sterile, clean-processed hood with an integrated pleated face mask, designed for use in GMP C/D (ISO Class 6–9) controlled environments. Ideal for pharmaceutical, biotech, and medical device manufacturing, this disposable accessory offers reliable protection and low particle shedding in cleanroom-grade processes that do not require aseptic (GMP A/B) handling.

Key Features:

• Bound internal seams and bound face opening
• Ties and loops for secure fit
• Integrated pleated blue face mask (17.5 cm wide, PE outer layer)
• Clean-processed and gamma sterilized (SAL 10⁻⁶, ISO 11137)
• Individually packed in double-bagged, cleanroom-compatible packaging
• Color: White hood with blue mask
• One size

Certifications & Standards:

• CE Category I (Partial Body Protection)
• Particle Cleanliness: Helmke Drum – Category I
• Bacterial Filtration Efficiency (BFE): 98.4% ± 0.9%
• Intended for use in ISO Class 6–9 / GMP C/D cleanrooms
• Full lot traceability and validated gamma irradiation

Note:

• Not suitable for GMP A/B or aseptic processing
• Not classified as PPE Category III or a medical device
• Mask is not certified as respiratory PPE (not FFP1/2/3 rated)

Recommended for:

• Pharmaceutical and biotech manufacturing (GMP C/D)
• Cleanroom support zones and non-aseptic processes
• Medical device assembly requiring sterile and low-lint accessories

For more information:
Tyvek® IsoClean® IC 982 B WH MS – DuPont