POWDER FREE NITRILE BLUE TEXTURED EXAMINATION GLOVE
Device Facts
| Record ID | K052877 |
|---|---|
| Device Name | POWDER FREE NITRILE BLUE TEXTURED EXAMINATION GLOVE |
| Applicant | Syntex Healthcare Products Co., Ltd. |
| Product Code | LZA · General Hospital |
| Decision Date | Nov 8, 2005 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6250 |
| Device Class | Class 1 |
Indications for 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 nitrile examination glove; textured surface; blue color. Worn by healthcare personnel on hands/fingers to provide barrier protection against patient body fluids, waste, and environmental contaminants. Device functions as a physical barrier; no electronic or mechanical components. Used in clinical settings to reduce cross-contamination risk between patient and examiner. Manufactured to meet ASTM D-6319-00E3 standards for physical dimensions and integrity.
Clinical Evidence
No clinical data. Bench testing only, including physical dimensions, water-tightness, residual powder content, and biocompatibility (skin irritation/sensitization).
Technological Characteristics
Material: Nitrile. Form factor: Powder-free, blue, textured examination glove. Standards: ASTM D-6319-00E3. Testing: FDA 1000 ml water fill test (AQL 2.5, G-1), residual powder test (ASTM D-6124-01, <2 mg/glove), and biocompatibility testing.
Indications for Use
Indicated for use by healthcare personnel as a disposable protective barrier worn on the hand or finger to prevent cross-contamination between the examiner and the patient.
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
- Shanghai Poseidon Plastic Products Co., Ltd. Nitrile Exam Gloves, Powder-Free, Color Blue (K001128)
Submission Summary (Full Text)
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EXHIBIT #1 Page 1 of 2
## 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: K052877
## 1. Submitter's Identification:
Mr. Hao Jun Jie Syntex Healthcare Products Co., Ltd. No. 1 Fanjiazhuang Industrial Zone Xinji City, Hebei, China
Date Summary Prepared: September 15, 2005
## 2. Name of the Device:
Syntex Healthcare Products Co., Ltd. Powder Free Nitrile Blue Textured Examination Glove
#### 3. Predicate Device Information:
Shanghai Poseidon Plastic Products Co., Ltd. Nitrile Exam Gloves, Powder-Free, Color Blue (K001128)
## 4. Device Description:
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Power-Free Nitrile Patient Examination Glove, 80 LZA, and meets all requirements of ASTM standard D-6319-00€3
## 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:
Syntex Healthcare Products Co., Ltd.'s Powder Free Nitrile Blue Textured Examination Glove is substantially equivalent in safety and effectiveness to the Shanghai Poseidon Plastic Products Co., Ltd.'s Nitrile Exam Gloves, Powder-Free, Color Blue.
## 7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as Follows:
The standards used for Syntex Healthcare Products Co., Ltd.'s glove production are based on ASTM-D-6319-00-3. 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 AOL 2.5. inspection level G-1, meeting these requirements. Primary Skin Irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions.
A Residual Powder Test that based on ASTM D-6124-01 for Starch at finished inspection is conducted to insure that our gloves meet our "powder-free" claims (contain no more than 2 mg powder per glove).
## 8. Labeling:
There are no special labeling claims and we do not claim our gloves as hypoallergenic on our labels.
#### 9. Discussion of Clinical Tests Performed:
Not Applicable - There is no hypoallergenic Claim.
#### 10. Conclusions:
Syntex Healthcare Products Co., Ltd.'s Powder Free Nitrile Blue Textured Examination Gloves conform fully to ASTM D-6319-00E 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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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 8 2005
Syntex Healthcare Products Company, Limited C/O Ms. Micky Lin Official Correspondent Gloveco, Incorporated 3973 Schaefer Avenue Chino, California 91710
Re: K052877
Trade/Device Name: Powder Free Nitrile Blue Textured Examination Glove Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: September 30 2005 Received: October 13, 2005
Dear Ms. Lin:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA). 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 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Lin
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Shi-Jie Li, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Attachment A
# INDICATIONS FOR USE
510(K) NUMBER (IF KNOWN): APPLICANT: DEVICE NAME:
Syntex Healthcare Products Co., Ltd. Powder Free Nitrile Blue Textured Examination Glove
INDICATIONS FOR USE:
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
| concurrent of CDRH, Office of Device Evaluation (ODE) |
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Vision Sign-Off)
Vision of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K052877
