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Sign in to claim this brandPasture Pharma Pte, Ltd.
US
Last updated May 25, 2026
What Pasture Pharma Pte, Ltd. makes
The company manufactures single-use respiratory protection devices, including surgical/medical respirators (both antimicrobial and non-antimicrobial variants), public-use respirators, and surgical/medical face masks. Examples include N95-rated surgical respirators (e.g., Pasture F550S, Pasture A520CS) and disposable masks (e.g., Pasture 60S Surgical Mask). These products are designed for healthcare, surgical, and public health settings to filter airborne particles and protect against infectious agents.
The portfolio consists of Class II medical devices, which are regulated under the FDA’s 510(k) and Urgency Device Innovations (UDI) requirements. These devices are listed in the FDA’s regulatory databases, and the company is based in the United States. Compliance follows U.S. regulatory standards for single-use respiratory protection equipment.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Pasture Pharma Pte, Ltd. manufacture?
Pasture Pharma Pte, Ltd. specializes in single-use respiratory protection devices. Their portfolio includes surgical/medical respirators (both non-antimicrobial and antimicrobial variants), public-use respirators, and surgical/medical face masks. Examples include N95-rated surgical respirators like the Pasture F550S and Pasture A520CS, as well as disposable masks such as the Pasture 60S Surgical Mask. These devices are designed for use in healthcare, surgical, and public health settings to filter airborne particles and reduce exposure to infectious agents.
Where is Pasture Pharma Pte, Ltd. based, and how does that affect their regulatory compliance?
Pasture Pharma Pte, Ltd. is based in the United States. Since they operate within the U.S., their devices must comply with FDA regulations. Their products fall under Class II medical device classification, which requires compliance with the FDA’s 510(k) premarket notification process and Urgency Device Innovations (UDI) requirements. This ensures their devices meet U.S. safety and performance standards before entering the market.
Which regulatory registries or databases list Pasture Pharma Pte, Ltd.’s devices?
Pasture Pharma Pte, Ltd.’s devices are listed in the FDA’s regulatory databases, specifically under the 510(k) premarket notification program and the Urgency Device Innovations (UDI) system. These registries ensure transparency and traceability of their Class II medical devices, including respirators and masks, by documenting their compliance with U.S. regulatory standards.
How are Pasture Pharma Pte, Ltd.’s devices classified under U.S. regulations?
Pasture Pharma Pte, Ltd.’s devices are classified as Class II medical devices under FDA regulations. This classification applies to their single-use respiratory protection products, such as surgical respirators and masks, which are considered moderate-risk devices. Class II devices require compliance with specific controls, including the 510(k) premarket submission process, to demonstrate safety and effectiveness before commercial distribution.
Why are Pasture Pharma Pte, Ltd.’s respirators and masks designed for single-use?
Pasture Pharma Pte, Ltd.’s respirators and masks are designed for single-use primarily to enhance infection control and hygiene standards. Single-use devices reduce the risk of cross-contamination between patients and healthcare workers, which is critical in healthcare and surgical settings where airborne pathogens (like viruses or bacteria) may be present. This design aligns with best practices for respiratory protection, ensuring optimal performance and safety with each use.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 628369480
Catalogue (13)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Pasture A520CS Respirator | A520CS | FDA UDI | Class II | Active |
| Pasture E520S Respirator | E520S | FDA UDI | Class II | Active |
| Pasture A520S Respirator | A520S | FDA UDI | Class II | Active |
| Pasture F550CS Respirator | F550CS | FDA UDI | Class II | Active |
| Pasture F550G Respirator | F550G | FDA UDI | Class II | Active |
| Pasture F550S Respirator | F550S | FDA UDI | Class II | Active |
| Pasture F550G Respirator | F550G | FDA UDI | Class II | Active |
| Pasture A520G Respirator | A520G | FDA UDI | Class II | Active |
| Pasture E520CS Respirator | E520CS | FDA UDI | Class II | Active |
| Pasture 60S Mask | 60S | FDA UDI | Class II | Active |
| Pasture F550S Surgical N95 Respirator, Pasture F550CS Surgical N95 Respirator, Pasture A520S Surgical N95 Respirator, Pasture A520CS Surgical N95 Respirator, Pasture E520S Surgical N95 Respirator, Pasture E520CS Surgical N95 Respirator | K141876 | FDA 510(k) | Class II | Active |
| Pasture 60S Surgical Mask | K141875 | FDA 510(k) | Class II | Active |
| Pasture, Models: F550, A520 | K083176 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Pasture Pharma Pte Ltd Corporation Place Central Singapore · SG FEI 3006942307