Quality and recalls
Report a product problem, ask about a recall notice or request a lot record.
Quality and documents
What we check, and what you receive.
Buyers ask what a distributor does to keep bad product out, and what paper arrives with the goods. This page answers both in the order the work happens: before a product is listed, with every quote, at receipt, and after delivery.
What GTDI is
A distributor that buys, invoices and keeps the records.
GTDI buys the product it sells on its own written purchase orders and invoices you directly. The manufacturer makes the product and holds the clearance, registration or approval. We check the documents, record what ships, and pass the manufacturer's notices to you.
Before a product is listed
Four checks, for every supplier and every product.
Documents from the supplier
The current, dated specification sheet. The regulatory identifiers and the item numbers they cover: the 510(k) number for exam gloves, masks and medical gowns, the NIOSH approval number for respirators, the EPA registration number for disinfectants, the NDC for hand sanitizer, or a food-contact statement naming the regulation. Test reports behind each performance claim. Photos of the box and case labels showing lot, manufacture date and GTIN. Units per box, boxes per case, case dimensions and pallet configuration. The manufacturer and country of manufacture.
Checked against the record
We check what the supplier sends against the manufacturer's own documents and the regulator's public records: the FDA 510(k) database, the NIOSH Certified Equipment List, EPA's registration records.
Recall and import alert check
We check FDA's recall database and import alerts for the products we sell at least quarterly and before each new purchase order to a supplier.
Supplier warranties
Every supplier warrants that each product is genuine, new and first quality, sourced from the manufacturer or its authorized distribution channel, is not diverted, relabeled, repackaged, expired or recalled, and was not made with forced labor. The full list is in the Supplier terms.
What is checked, by product type
The status on the page. The number on your quote.
Regulatory record numbers identify the manufacturer, so they appear on your written quote rather than on public pages. Each public page states the status in the agency's own words.
Scroll sideways to see every column
| Product type | Status checked | Where to verify it yourself |
|---|---|---|
| Patient examination gloves | FDA 510(k) clearance as a patient examination glove, with the product code | FDA 510(k) database, by the K number on your quote |
| Chemotherapy-tested gloves | The ASTM D6978 drug list and breakthrough times in the cleared labeling | The 510(k) summary linked from the FDA record |
| Surgical and procedure masks | FDA 510(k) clearance and the ASTM F2100 level with its test values | FDA 510(k) database |
| N95 respirators | NIOSH approval and, for surgical N95 models, FDA Class II status | NIOSH Certified Equipment List, by the TC number on your quote |
| Gowns | ANSI/AAMI PB70 level and FDA status by gown type. Surgical and surgical isolation gowns are 510(k) cleared. Non-surgical isolation gowns are Class I and exempt. | FDA 510(k) database where a K number exists |
| Disinfectants | EPA registration and the organism claims and contact times on the EPA-accepted label | EPA pesticide product label system, by the registration number on your quote |
| Hand sanitizer | Over-the-counter drug status and the Drug Facts label | FDA's hand sanitizer notices and recall database |
| Food-service and industrial gloves | The manufacturer's food-contact statement or test reports. Not medical devices. | The manufacturer's declaration, supplied with your quote |
With every quote
The quote is the document.
Every written quote states, for each line:
- GTDI item code and the generic description
- Manufacturer, brand and manufacturer part number
- The regulatory identifier that applies: 510(k) number, NIOSH TC number, EPA registration number or NDC
- Country of origin
- Units per box and boxes per case, by size
- Price per case and, for gloves, per 1,000 gloves
- Freight basis, estimated lead time and payment terms
- Valid-until date and the substitution rule
Documents on request, at quote stage: the specification sheet, the 510(k) record, test reports behind a claim, the safety data sheet where the product has one, and a lot certificate of analysis where the manufacturer issues one. For chemotherapy-tested gloves, the tested drug list with breakthrough times.
Ask your representative, or list the documents you need in the notes on your quote request.
At receipt and after delivery
Lot records on every order.
With the shipment. After shipment we send the carrier's name and the tracking or PRO number. Shipments that go straight from a supplier to you carry GTDI or neutral packing slips, with no supplier invoice or pricing in the box.
Lot records. For every order we record the products supplied and the lot numbers shipped, as our suppliers report them. These records show which deliveries a recall affects.
Complaints. We record every product complaint we receive and report it to the manufacturer, and we keep the record as federal device regulations require of distributors. If a product problem may have affected someone's health, follow your facility's procedures and consider reporting it to FDA through MedWatch.
Defects. Stop using the affected box and keep the product, the box and its lot number. Tell your representative, with photos if you can. We work with the manufacturer under its warranty to replace the product or issue a credit.
Recalls
Notice within one business day.
The manufacturer directs each recall. We notify you, identify the affected shipments, and coordinate returns, replacements and credits.
We learn of the recall
From the manufacturer, from the supplier we bought from, whose terms require notice within one business day, or from our checks of FDA's recall database and import alerts.
We contact you
By phone and by email, within one business day after we learn of it, to the people on your account and the recall contact you named.
The notice states
The product, manufacturer and item number. The lot numbers we shipped to you. The reason and classification as FDA or the manufacturer states them. The manufacturer's instructions. How returns, replacements or credits are handled. Your representative's direct contact. A link to FDA's recall record once it is posted.
You confirm and set product aside
Confirm receipt of the notice, check stock by lot number, set affected product aside, follow the manufacturer's instructions and tell us how many units you hold. We arrange replacement or credit.
Credentials
Licences, registrations and insurance, in the vendor packet.
Licences, registrations and a certificate of insurance are provided in the vendor packet on request, together with our Form W-9. Each document names the issuing body and the number, so your vendor team can verify it with the issuer.
GTDI is a distributor. Specifications, regulatory clearances, labeling and instructions for use are the manufacturer's. The 510(k) clearance, NIOSH approval or EPA registration belongs to the product on your quote, and the quote tells you where to check it.
Restricted items
Items supplied only to authorized buyers.
Needles, syringes, other devices labeled Rx only, and professional-use test kits are supplied only to buyers authorized to receive them under applicable federal and state law. Buyer licence details are collected before the first shipment, and we keep a record of each sale as the law requires. The terms are in the Terms and conditions of sale.
Contacts
Quality and recalls, by function.
Documents
Specification sheets, 510(k) records, safety data sheets and certificates of analysis, on request.
Vendor packet
W-9, certificate of insurance, licences and registrations for your vendor file.
Talk to the accounts team.
Phone, email and address are the same on every page of this site, on every quote and on every invoice.
- Phone 424-832-6485
- Email sales@gtdi.net
- Hours Monday to Friday, 8 a.m. to 5 p.m. Pacific
- Address GTDI, 200 S Barrington Ave, Los Angeles, CA 90049
Your first contact is the GTDI accounts team. Existing accounts: your representative's direct contact is on your account dashboard.