Gerson 3230+ Surgical N95 Respirator – FDA Cleared, NIOSH Approved (Box of 50)

The Gerson 3230+ Surgical N95 Respirator is an FDA-cleared, NIOSH-approved foldable pouch-style mask designed for healthcare, industrial, and emergency response applications. Manufactured at Gerson's ISO 9001:2015 certified facility in Middleboro, MA, it meets CDC guidelines for TB exposure control and fulfills OSHA's hospital respiratory protection requirements. Each box contains 50 individually wrapped respirators.

For facilities requiring a dual-certified surgical/N95 respirator — one that delivers both particulate filtration and splash protection — the 3230+ represents the entry point in Gerson's healthcare-grade lineup.

Construction and Materials

The 3230+ uses a foldable duckbill design with electrostatically charged filter media. The outer shell is fluid-resistant; the inner liner is soft fleece-like material that reduces skin irritation during extended wear. Synthetic rubber head straps are latex-free and require no pre-stretching. An adjustable nosepiece minimizes eyewear fogging. Construction is staple-free throughout.

Compliance and Ratings

NIOSH approval TC-84A-9317 certifies ≥95% filtration efficiency against non-oil-based airborne particles per 42 CFR Part 84. FDA clearance as a surgical respirator adds fluid resistance rated at 120 mm Hg. The respirator meets CDC guidelines for Mycobacterium tuberculosis exposure control.

Performance

Inhalation resistance of 6.7–6.4 mm H₂O and exhalation resistance of 5.1 mm H₂O place the 3230+ among the lowest-resistance N95 designs on the market. In healthcare settings requiring continuous wear across a shift, this translates directly to reduced wearer fatigue. The duckbill profile creates a natural air pocket in front of the mouth, which further reduces the sensation of heat accumulation.

Strengths

• Dual certification — N95 filtration plus FDA surgical clearance
• Up to 50% lower breathing resistance versus standard molded N95 cup designs
• Individual wrapping for hygienic dispensing and field storage
• Latex-free, staple-free construction appropriate for sterile environments
• Made in USA with over 35 years of NIOSH-certified manufacturing

Limitations

• Duckbill profile may not fit smaller facial structures as securely as fitted molded cup designs
• No exhalation valve — exhaled air is filtered through the mask material, which increases exhalation resistance relative to valved models
• N-series rating does not cover oil-based aerosols

Recommended Use Cases

The 3230+ is the standard choice for hospitals, clinics, dental offices, and laboratories requiring NIOSH N95 plus surgical clearance from a single mask. Industrial applications in non-oil environments — pharmaceutical manufacturing, food processing, laboratory operations — benefit from the dual certification without overpaying for features not required by OSHA's respiratory protection standard.

Verdict

The Gerson 3230+ Surgical N95 Respirator fulfills both OSHA 29 CFR 1910.134 N95 requirements and FDA surgical mask standards in a single SKU. Facilities that can purchase based on one SKU rather than two separate products will find this consolidation operationally valuable. For non-surgical industrial applications, the Gerson 1730 molded cup provides comparable N95 protection at a lower cost per unit.

FAQ

What is the NIOSH approval number for the Gerson 3230+?

TC-84A-9317. This approval certifies ≥95% filtration efficiency against non-oil-based airborne particles. The earlier 3230 model carries TC-84A-9285.

Is the Gerson 3230+ FDA cleared as a surgical mask?

Yes. The 3230+ is FDA cleared as a surgical respirator, meeting ASTM F2100 fluid resistance requirements at 120 mm Hg. This makes it suitable for use in surgical environments where both particulate filtration and splash protection are required.

How does the 3230+ compare to a standard N95 cup respirator for breathing resistance?

The 3230+ measures 6.7–6.4 mm H₂O inhalation resistance versus approximately 10–13 mm H₂O for most molded N95 cups. This represents up to 50% lower breathing resistance, which reduces fatigue during extended wear shifts.

Does the Gerson 3230+ have an exhalation valve?

No. The 3230+ is an unvalved design. Exhaled air passes through the filter media. This is required for surgical applications — an exhalation valve would allow unfiltered exhaled air to reach the surgical field.

How many respirators are in a box and a case?

Each box contains 50 individually wrapped respirators. A standard case contains 4 boxes (200 total). The EZ-GO Zip Pak variant contains 5 per bag, 40 bags per case (200 total).