Wholesale Distributor · N95 Respiratory Protection

FDA-cleared surgical N95.
NIOSH-certified industrial N95.
Delivered to your warehouse.

SHLD MED is the authorized U.S. wholesale distributor of Guangzhou Harley N95 respirators. Two SKUs. Two certifications. One supplier — direct to procurement, no middlemen.

FDA 510(k) CLEARED
NIOSH TC-84A APPROVED
Request Documentation → View Product Line
FDA 510(k)
S-188N
TC-84A-9381
$0.65
PER MASK · MOQ 2 CASES
NIOSH
L-188
TC-84A-6973
$0.50
PER MASK · MOQ 2 CASES
$11M
Revenue · 2020 COVID Response
≥95%
Particulate Filtration Efficiency
2 SKUs
FDA + NIOSH Channels
DDP
Delivered Duty Paid
Product Line · 02

Two SKUs. One decision.

Healthcare procurement requires FDA 510(k). Industrial, commercial, and government channels require NIOSH TC-84A. We carry both — from a single supplier, with a single ordering relationship.

FDA 510(k) CLEARED · SURGICAL N95
S-188N
Guangzhou Harley · Surgical N95 Respirator
CertificationFDA 510(k) + TC-84A-9381
Filtration≥95% particulate efficiency
DesignFoldable, ergonomic 3D structure
Material3-layer PP non-woven + melt-blown
Nose PieceAdjustable padded metal clip
Pack20 / box · 25 boxes / case (500)
Intended UseHospital · Clinic · Surgical
Box of 20
$13.00
$0.65 / mask
Case of 500
$325
MOQ: 2 cases
NIOSH TC-84A-6973 · INDUSTRIAL N95
L-188
Guangzhou Harley · Industrial N95 Respirator
CertificationNIOSH TC-84A-6973
Filtration≥95% particulate efficiency
DesignFlat-fold, lightweight, portable
Material3-layer PP non-woven + melt-blown
Nose PieceFlexible metal clip, adjustable
Pack20 / box · 25 boxes / case (500)
Intended UseIndustrial · Construction · Govt.
Box of 20
$10.00
$0.50 / mask
Case of 500
$250
MOQ: 2 cases
Certifications & Compliance · 03

Official documentation on request.

Full certification packages — NIOSH approval letters, FDA 510(k) clearance, lot numbers, and COAs — are provided under signed NDA or purchase agreement.

NIOSH Approval · L-188
TC-84A-6973
Issued by CDC/NIOSH National Personal Protective Technology Laboratory on December 15, 2014 to Guangzhou Harley Commodity Company Limited. Reference TN-19824.
NIOSH Approval · S-188N
TC-84A-9381
NIOSH-certified surgical N95 respirator. Meets or exceeds N95 filtration standards per 42 CFR Part 84 for healthcare and industrial use.
FDA 510(k) Clearance · Surgical N95
FDA Cleared
Cleared for healthcare settings including hospitals, clinics, and surgical environments. Full 510(k) documentation available upon request.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Centers for Disease Control · NIOSH/NPPTL
NIOSH Reference: TN-19824
MR Reference: GHCL-188
Date: December 15, 2014

Mr. Wanghua Xu — Management Representative
Guangzhou Harley Commodity Company Limited
Floor 1 to 4, #8, Team 17, Sandong Village
Xinhua Street, Huadu District
Guangzhou 510800, CHINA

The National Institute for Occupational Safety and Health (NIOSH) has reviewed the request accepted September 17, 2014 for approval of model L-188 N95 filtering facepiece air-purifying respirator…

Approval number TC-84A-6973 has been assigned. This respirator is approved for protection against particulates at a N95 filter efficiency level.
Full approval letter · provided on request
Target Buyers · 04

Built for procurement teams.

Match the certification to the channel. We supply both — and we know which one your category requires.

FDA 510(k)
Hospitals & Health Systems
  • Hospital GPO procurement
  • Independent supply chains
  • Ambulatory surgery centers
  • Home health agencies
FDA 510(k)
Clinics & Dental
  • Dental DSOs & group practices
  • Urgent care chains
  • Specialty clinics
  • Long-term care facilities
NIOSH TC-84A
Construction & Industrial
  • General contractors (OSHA)
  • Safety distributors
  • Manufacturing plant safety
  • Oil & gas operations
Also serving: Schools & Universities · Government & Municipal · Corporate & Office · All NIOSH TC-84A Channel
Capabilities Deck · 05

Full capabilities documentation.

Ten-slide capabilities deck covering product line, certifications, pricing, volume discounts, and order terms. Download the PDF or view inline.

PDF
SHLD MED Capabilities Deck
Download Deck (PDF) ↓ Email Sales
Why SHLD MED · 06

Proven supply.
Real credentials.

01 / BATTLE-TESTED SUPPLIER
$11M moved during 2020.
We distributed Guangzhou Harley N95s at scale during the COVID-19 response. We know this product, this supplier, and large-volume delivery logistics — not theoretically, operationally.
02 / RIGHT CERT FOR EVERY CHANNEL
FDA for healthcare. NIOSH for industrial.
Two SKUs covering both regulated channels under one vendor relationship. No mismatched certifications, no procurement compliance gaps.
03 / SIMPLE, HONEST PRICING
$0.65 FDA. $0.50 NIOSH.
No tiered confusion. Volume discounts begin at 10 cases — 3% / 6% / 10% at the 10 / 50 / 100 case thresholds. 90-day price validity.
04 / DDP — WE HANDLE LOGISTICS
Delivered Duty Paid to your warehouse.
We manage import, customs, and last-mile so your procurement team doesn't. Net 30 terms. 90-day delivery window from PO.
Ready to Order

Two SKUs. One supplier.
Documentation on day one.

Email orders@shldmed.com → View Pricing & MOQ
MOQ: 2 Cases (1,000 Masks) Net 30 · DDP 90-Day Price Validity