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Safe-T-Seal

by Gs Medical Packaging, Inc.

510(k) K953829

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK953829 Date9 Nov 1995ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KCT
Device Class
Class II
Regulation
21 CFR Part 880.6850
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Safe-T-Seal is a sterile barrier system designed to protect medical devices and instruments during storage and sterilisation. It is classified as a medical packaging device, ensuring contamination control and maintaining sterility until use in clinical settings.

This device is supplied as a single-use, sterile barrier and is intended for use in general hospital environments. It is authorised under FDA 510(k) clearance (K953829) and falls under product code KCT, with no third-party review. Storage conditions must adhere to manufacturer guidelines to preserve sterility and integrity.

Other devices from Gs Medical Packaging, Inc.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Safe-T-Seal primarily used for in a clinical setting?

    The Safe-T-Seal is designed as a sterile barrier system to protect medical devices and instruments during storage and sterilization. Its purpose is to maintain contamination control and preserve sterility until the items are ready for use in general hospital environments.

  • Is the Safe-T-Seal intended for reuse, or is it meant to be used only once?

    The Safe-T-Seal is explicitly labeled as a single-use sterile barrier system. This means it is engineered for one-time use to ensure sterility and prevent contamination, aligning with best practices for medical packaging.

  • How should I store the Safe-T-Seal to ensure it remains effective?

    To maintain sterility and integrity, storage must follow the manufacturer’s guidelines provided by Gs Medical Packaging, Inc. While specific conditions aren’t detailed here, adhering to standard sterile packaging protocols—such as avoiding moisture, extreme temperatures, or physical damage—is critical.

  • What regulatory pathway was followed for FDA clearance of the Safe-T-Seal?

    The Safe-T-Seal received FDA clearance through a 510(k) submission (K953829) under the Traditional review pathway, with a Substantially Equivalent determination. It was filed under product code KCT (General Hospital) and did not involve third-party review.