Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027977504

FEI Number

3027977504

Entity Name

MEDLINE CHILE SPA

City/State/Country

Pudahuel Region Metropolitana, CL

Establishment Address

Ave. Boulevard Poniente 1313 Bodenor Flexcenter, Pudahuel Region Metropolitana 9031287, CL

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Medline Chile SPA (Owner Number: 10088604)

Owner / Operator Contact Address

Ave. Boulevard Poniente 1313 Bodenor Flexcenter, Pudahuel, CL-NOTA 9031287, CL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Medical Glove SensiCare Neoprene Disposable Bedding Non-Surgical Gown SensiCare PI Micro

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2026-02-24
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2026-02-18
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2026-02-24
LWK	Razor, Surgical	General, Plastic Surgery	Class 1	878.4800	2026-02-18
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2024-02-07
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2024-02-07
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2026-03-24
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2026-02-18
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2026-03-24
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2026-03-24
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2026-02-18
HBA	Neurosurgical Paddie	Neurology	Class 2	882.4700	2026-03-24
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2026-03-24
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2026-02-24
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2026-02-24
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2026-02-18
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2026-02-18
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2026-02-18
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2026-05-08
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2026-05-08
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2026-03-24
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2026-02-18
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2026-03-24
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	2026-03-24
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2023-08-28
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2023-08-28
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2026-02-24
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2026-02-18
GBW	Catheter, Peritoneal	General, Plastic Surgery	Class 1	878.4200	2026-03-24
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2026-02-18
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2026-03-24
QQS	Stapler, Skin	General Hospital	Class 1	878.4740	2026-02-18
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2026-03-24
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2026-05-08
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2026-05-08
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2026-03-24
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2026-02-18
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2026-03-24
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2026-02-18
PNR	Enteral Syringes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2026-03-24
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2026-02-18
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2026-02-24
GAB	Needle, Suturing, Disposable	General, Plastic Surgery	Class 1	878.4800	2026-03-24

Official Correspondent

Stephanie Augsburg

US Agent Details

Rosanna Lee Business: Simcon International LLC Email: rlee@simconintl.com Phone: (847) 9492290

Related Public Records

Same Entity

Medline Chile SPA

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
K892118	Paramount Products, Inc.	NON-STERILE MASKS AND CAPS	1989-04-20
K962045	Mallinckrodt Medical	ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT	1996-11-26
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0017-2019	COVIDIEN LLC	1	Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027977504. Last updated year: 2026. Please use registration number 3027977504 when referencing this establishment in official correspondence.