Question 1

What types of medical devices does Purcel Labs LLC manufacture?

Accepted Answer

Purcel Labs LLC produces a range of single-use medical devices, including nitrile and vinyl examination gloves (non-powdered and non-antimicrobial), autoinjector needles, blood lancets for diabetic testing, surgical/medical respirators, and home-use glucose monitoring systems. Their portfolio also covers individually wrapped surgical masks meeting ASTM Level 1 standards. These devices are designed for medical, diagnostic, and personal protective applications.

Question 2

Where is Purcel Labs LLC based, and how does that affect its devices?

Accepted Answer

Purcel Labs LLC is based in the United States, which means its devices are subject to U.S. regulatory requirements, including FDA oversight. The company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. medical device regulations.

Question 3

Which regulatory registries or databases list Purcel Labs LLC’s devices?

Accepted Answer

Purcel Labs LLC’s devices are primarily listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices under U.S. regulatory frameworks, ensuring transparency and compliance for Class I and Class II products.

Question 4

How are Purcel Labs LLC’s devices classified under FDA regulations?

Accepted Answer

Purcel Labs LLC’s devices fall under FDA’s Class I and Class II classifications. Class I generally includes low-risk devices like gloves and surgical masks, while Class II covers moderate-risk items such as blood lancets and glucose monitoring systems. Classification determines the regulatory controls applied to ensure safety and effectiveness.

Device	Model / Reference	Registries	Class	Status
PurCel Labs Small 4 MIL Black Exam Gloves	1400-100	FDA UDI	Class I	Active
PurCel Labs Large Vinyl Exam Gloves	1202-150	FDA UDI	Class I	Active
PurCel Labs Easy Result Blood Glucose Meter	1130	FDA UDI	Class II	Active
PurCel Labs Medium Vinyl Exam Gloves	1201-150	FDA UDI	Class I	Active
PurCel Labs Safety Insulin Pen Needles (32G x 4mm)	1086-100	FDA UDI	Class II	Active
PurCel Labs Small Vinyl Exam Gloves	1200-150	FDA UDI	Class I	Active
PurCel Labs ASTM Level 1 Surgical Masks	3000-50	FDA UDI	Class II	Active
PurCel Labs Individually Wrapped ASTM Level 1 Surgical Masks	3001-50	FDA UDI	Class II	Active
PurCel Labs Safety Lancets Push-Button (30G x 1.5mm)	1100-100	FDA UDI	Class II	Active
PurCel Labs Safety Insulin Pen Needles (30G x 6mm)	1088-100	FDA UDI	Class II	Active
PurCel Labs Medium 4 MIL Black Exam Gloves	1401-100	FDA UDI	Class I	Active
PurCel Labs XL 4 MIL Black Exam Gloves	1403-100	FDA UDI	Class I	Active
PurCel Labs Large 4 MIL Black Exam Gloves	1402-100	FDA UDI	Class I	Active
PurCel Labs Safety Insulin Pen Needles (31G x 5mm)	1087-100	FDA UDI	Class II	Active
PurCel Labs XL Vinyl Exam Gloves	1203-150	FDA UDI	Class I	Active

Purcel Labs LLC

What Purcel Labs LLC makes

Frequently asked questions

Information

Catalogue (15)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities