SHANG HO

K970795 · Shang HO Industrial Corp. , Ltd. · KGO · Dec 18, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K970795
• Device Name: SHANG HO
• Applicant: Shang HO Industrial Corp. , Ltd.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Dec 18, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

A Surgeon's Gloves is worn on the hand of operating room personnel to protect surgical wound from contamination and prevent contamination between operating room personnel and patient.

Device Story

Powder-free latex surgical gloves; worn by operating room personnel; provides barrier protection for surgical wounds; prevents cross-contamination between patient and clinician; intended for use in surgical environments.

Clinical Evidence

Bench testing only.

Technological Characteristics

Powder-free latex material; surgical glove form factor; sterile.

Indications for Use

Indicated for use by operating room personnel to protect surgical wounds from contamination and prevent cross-contamination between personnel and patients.

Regulatory Classification

Identification

A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. Cheng Ko Lin
President
Shang Ho Industrial Corp Ltd.
4-5, Nan Pei 1st Rd
Chiang Li, Tachia, Taichung Hsien
Taiwai, R.O.C.

Re: K970795
Trade Name: Shang Ho Powder Free Latex Surgical Gloves
Regulatory Class: I
Product Code: KGO
Dated: September 30, 1997
Received: September 30, 1997

Dear Mr. Lin:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

DEC 18 1997

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Page 2 - Mr. Lin

through 542 of the Act for devices under the Electronic
Product Radiation Control provisions, or other Federal laws or
regulations.

This letter will allow you to begin marketing your device as
described in your 510(k) premarket notification. The FDA
finding of substantial equivalence of your device to a legally
marketed predicate device results in a classification for your
device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling
regulation (21 CFR Part 801 and additionally 809.10 for in
vitro diagnostic devices), please contact the Office of
Compliance at [phone]. Additionally, for questions on
the promotion and advertising of your device, please contact
the Office of Compliance at [phone]. Also, please note
the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general
information on your responsibilities under the Act may be
obtained from the Division of Small Manufacturers Assistance
at its toll-free number [phone] or [phone] or at
its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski
Director
Division of Dental, Infection Control
and General Hospital Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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Attachment M

# Indication For Use Statement

510K Number (if known): Applied for K 970795

Device Name: Powder Free SterilSurgeon's Gloves

Indications For Use:

A Surgeon's Gloves is worn on the hand of operating room personnel to protect surgical wound from contamination and prevent contamination between operating room personnel and patient.

Shang Ho Industrial Corp. Ltd.

X Cheng Ko Lin

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices

510(k) Number K 970795

Prescription Use OR

(Per 21 CFR 801.109)

Over-The-Counter Use ☑

(Optional Format 1-2-96)