Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1043549

FEI Number

1043549

Entity Name

Haywood Vocational Opportunities Inc.

City/State/Country

Waynesville, NC, US

Establishment Address

150 Westwood Circle, Waynesville, NC 28786, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Haywood Vocational Opportunities Inc. (Owner Number: 1043549)

Owner / Operator Contact Address

150 Westwood Circle, --, Waynesville, NC 28786, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

581725

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2016-10-17
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2016-10-17
HMT	Drape, Patient, Ophthalmic	General, Plastic Surgery	Class 2	878.4370	2012-11-15
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2018-07-24
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2016-10-17
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2016-10-17
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2016-10-17
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2012-11-14
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2012-11-14
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2012-11-15
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-06-11
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2016-10-17
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2016-10-17
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2012-11-14
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2016-10-17
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2018-02-20
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2016-10-17
EYD	Stirrups	Gastroenterology, Urology	Class 1	876.4890	2019-07-02
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2016-10-17
FPY	Sheet, Burn	General Hospital	Class 1	880.5180	2012-11-14
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2016-10-17
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2016-10-05
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2016-10-17
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2016-10-17
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2016-10-17
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2016-10-17
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2012-11-14
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2012-11-14
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2016-10-17
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2016-10-17
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2016-10-17
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2012-11-14

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Haywood Vocational Opportunities Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K212801	Hong Seng Gloves Sdn Bhd	Powder free nitrile examination glove- black, non sterile	2022-01-09
K260806	Vista Industries,, LLC	Nitrile Disposable Examination Gloves	2026-06-03
K011593	Ansell Healthcare Products, Inc.	MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE	2001-06-21
K981039	Sri Johani Sdn. Bhd.	POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED)	1998-04-21
K101595	Better Care Plastic Technology Cp., Ltd.	POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE	2010-08-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2013	Accuro Medical Product LLC	2	Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical Products LLC, 2854 Hitchcock Ave, Downers Grove, IL 60515; part number 84635400182, sold inside the Apex Negative Wound Therapy system, part number 84635400181 Promotes wound healing through drainage and removal of infectious material and other fluids from the wound site using continuous and/or intermittent negative pressure. Types of wounds indicated include diabetic/neuropathic ulcers, pressure ulcers, chronic wounds, acute wounds and dehisced wounds.
Z-0039-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Z-0040-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Z-0041-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1043549. Last updated year: 2026. Please use registration number 1043549 when referencing this establishment in official correspondence.