POWDERED SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES

K011883 · Shijiazhuang Eversharp Plastic Products Co., Ltd. · LYZ · Jul 17, 2001 · General Hospital

Device Facts

• Record ID: K011883
• Device Name: POWDERED SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES
• Applicant: Shijiazhuang Eversharp Plastic Products Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Jul 17, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

Device Story

Disposable synthetic (yellow) vinyl patient examination glove; worn by healthcare personnel on hands/fingers; acts as physical barrier to prevent cross-contamination between patient and examiner; protects against contact with body fluids, waste, or environment. Device is non-sterile, powdered with absorbable dusting powder (USP).

Clinical Evidence

No clinical data. Bench testing only: physical dimensions, AQL 4.0 inspection, 1000 ml water fill test (AQL 2.5), and primary skin irritation/sensitization testing.

Technological Characteristics

Synthetic (yellow) vinyl material; powdered with absorbable dusting powder (USP); conforms to ASTM D5250-00; physical dimensions and pinhole testing per FDA requirements; biocompatible.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Regulatory Classification

Identification

A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

Predicate Devices

• Shijiazhuang Great Eagle Plastic Products Co., Ltd. Synthetic Powdered (Yellow) Vinyl Patient Examination Gloves (K992862)

Submission Summary (Full Text)

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# JUL 1 7 2001

# 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________

# 1. Submitter's Identification:

Mr. Yinhai Wang Shijiazhuang Eversharp Plastics Products Co., Ltd. No. 312 East Long Quan Road Luquan, Hebei Province P.R. China

Date Summary Prepared: May 11, 2001

## 2. Name of the Device:

Shijiazhuang Eversharp Plastics Products Co., Ltd. Powdered Synthetic (Yellow) Vinyl Patient Examination Gloves

### 3. Predicate Device Information:

Shijiazhuang Great Eagle Plastic Products Co., Ltd.

Synthetic Powdered (Yellow) Vinyl Patient Examination Gloves K#992862

#### Device Description: 4.

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powdered Vinyl Patient Examination Glove, 80LYZ, Powdered with Absorbable Dusting Powder, USP, Class III and meets all requirements of ASTM Standard D5250-00.

### 5. Intended Use:

A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

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## 6. Comparison to Predicate Devices:

Shijiazhuang Eversharp Plastics Products Co., Ltd. Powdered Synthetic (Yellow) Vinyl Patient Examination Gloves, is substantially equivalent in safety and v firy Futuring Litaniang Great Eagle Plastic Products Co., Ltd. Synthetic Powdered (Yellow) Vinyl Patient Examination Gloves.

# 7. Discussion of Non-Clinical tests Performed for Determination of Substantial Equivalence are as follows:

The standards used for Shijiazhuang Eversharp Plastics Products Co., Ltd. glove Frie standards about on ASTM-D-5250-00. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQL 4.0.

The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5, Inspection Level I, meeting these requirements. Primary Skin irritation and Skin mispection 2019, in the contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions.

There are no special labeling claims and we do not claim our gloves as hypoallergenic on our labels.

### Discussion of Clinical Tests Performed: 8.

Not Applicable - There is no hypoallergenic Claim.

## 9. Conclusions:

Shijiazhuang Eversharp Plastics Co., Ltd. Powdered Synthetic (Yellow) Vinyl Patient Examination gloves conform fully to ASTM-D-5250-00 standard as well as applicable 21 CFR references, and, meets pinhole FDA requirements, biocompatibility requirements and labeling claims as shown by data in Section 7. There are no safety/efficacy issues or new claims from the "substantial equivalence" products cited.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 7 2001

Shijiazhuang Eversharp Plastic Products Co., Ltd. C/O Mr. James Chu Official Correspondent Gloveco, Incorporated 12390 East End Avenue Chino, California 91710

K011883 Re : Powdered Synthetic (Yellow) Vinyl Trade/Device Name: Patient Examination Gloves 880.6250 Regulation Number: Regulatory Class: I Product Code: LYZ Dated: May 18, 2001 Received: June 18, 2001

Dear Mr. Chu:

We have reviewed your Section 510(k) notification of intent to we have reviewed your beceren. beve and we have determined the market the device ferenced above (for the indications for device is substancially organismination to Merceded predicate use stated in the encrobare, or Ing 2002 - 1976, devices marketed in theerbead of the Medical Device Amendments, or to the enactment uate of the hearonial in accordance with the devices that have been recrably Drug, and Cosmetic Act (Act).
provisions of the Federal Food, Drug, and Cosmetic the general provisions of the reacrar rood, broy, subject to the general The general controls controls provisions of the Act. controls provisions of include requirements for annual provisions of the Act incraac request manufacturing practice, registration, freeing or a a a misbranding and adulteration.

If your device is classified (see above) into either class II II your device is crabbirsa (so(remarket Approval), it may (Special Concrols) of Stiphal controls. Existing major be subject to such address.ar be found in the Code of regulations arrecting foll 21, Parts 800 to 895. ਸੋ Federal Regulations, freic ar, basemes compliance with substancially equivalEacturing Practice requirements, as set the Current Sood hands as the System Regulation (QS) for Medical Lorch In the Quarrey ByBoom Kogard Rogart 820) and that, Devices: General regarations, the Food and Drug through periodic QS inspections, ench assumptions. Failure to
Administration (FDA) will verify such in romany in romal tory Administracton (FBA) will result in regulation may result in regulatory

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Page 2 - Mr. Chu

In addition, FDA may publish further announcements Please note: action. action. In addition, First May paderal Register.
concerning your device in the Federal Register. concerning your device in the reductions.
this response to your premarket notification submission does this response to your premarket noctrreactor same not affect any obligation you might made the Electronic
through 542 of the Act for devices under the Electronic through 542 of the Act for devices under the Becorement of the regulations.

This letter will allow you to begin marketing your device as the FDA This letter will allow you to begin mainteeung your man fDA
described in your 510(k) premarket notification. The f described in your 510(k) premarker not receive to a legally
finding of substantial equivalence of your device to a legally finding of substantial equivalence of your actises on for your marketed predicate device results in a crabblession and the market.

If you desire specific advice for your device on our labeling a
nd for and a FFP Bost 801 additionally 809.10 for in If you desire specific advice for your and additionally 809.10 for in
regulation (21 CFR Part 801 and additionally 809.10 for in regulation (21 CFR Part 801 and additionaly, for guestic vitro diagnostic devices), please conculture on one on on Compliance at [phone]. Address, as a sease contact
the promotion and advertising of your device, please not the promotion and advertising of [phone]. Also, please note
the Office of Compliance at [phone]. Also, professor (3 the Office of Compriands wisbranding by reference to Other general the regarde-staffication" (21CFR 807.97). premarket notification" (21CHK 807.97). October 2017
information on your responsibilities under the Act may be information on your responsibilities under the 110 mm]
obtained from the Division of Small Manufacturers Assistance
11 for all for mumber [phone] or [phone] or obtained from the Division of Smarr Manufaceared on 2011
at its toll-free number [phone] or [phone] or at its internet address

its internet address
"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours

Timothy A. Ulatowski

Timothy Director 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 A

Page 1 of 1

KO11883 (IF KNOWN) : 510(K) NUMBER Shijiazhuang Eversharp Plastics Products Co., Ltd. DEVICE NAME: INDICATIONS FOR USE: Powdered Synthetic (Yellow) Vinyl Patient Examination Gloves

A patient examination glove is disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Qlin S. hin

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic 513;k) Number .

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

Concurrent of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter-Use (Optional Format 1-2-96)