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FDA 510(k)

Surgical Face Masks (Ear loops and Tie-on)

K-Number: K160269 · 2016-09-06

ApplicantSan-M Package Co., Ltd.
Decision Date2016-09-06
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Surgical Face Masks (Ear loops and Tie-on) is the device name listed in this FDA 510(k) record. The listed applicant is San-M Package Co., Ltd.. It received FDA 510(k) clearance on 2016-09-06 under 510(k) number K160269. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Surgical Face Masks (Ear loops and Tie-on)?

Surgical Face Masks (Ear loops and Tie-on) is a medical device that received FDA 510(k) clearance on 2016-09-06. The listed applicant is San-M Package Co., Ltd.. The 510(k) number is K160269.

When did Surgical Face Masks (Ear loops and Tie-on) receive FDA 510(k) clearance?

Surgical Face Masks (Ear loops and Tie-on) received FDA 510(k) clearance on 2016-09-06, under 510(k) number K160269.

Who is the listed applicant for Surgical Face Masks (Ear loops and Tie-on)?

The FDA 510(k) record lists San-M Package Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Surgical Face Masks (Ear loops and Tie-on)?

The FDA product code for Surgical Face Masks (Ear loops and Tie-on) is FXX.

Other records listing San-M Package Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221534Surgical Face Masks (Ear Loops And Tie-On)K160271N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12

Related Devices (Code: FXX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251967HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround VisorO&M Halyard, Inc.K252534Surgical Face Mask (Ear mount)Zhejiang Hangkang Medical Equipment Co., Ltd.K253398Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)Efofex, Inc.K252830Disposable Surgical Face Mask (3P00B, C2900)Beatles Medical Supplies (Xiantao) Co., Ltd.K252650Disposable Medical Face MaskMakrite Industries, Inc.K243342KP Protective Face MaskKp Trading Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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