(84 days)
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.
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.
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Power-Free Vinyl Patient Examination Gloves, 80 LYZ, and meets all requirements of ASTM standard D-5250-00E4.
The provided text describes the 510(k) summary for the Shijiazhuang Lianhe Shunda Plastic Products Co., Ltd. Powder Free (White) Vinyl Patient Examination Gloves.
This document is a premarket notification for a Class I medical device (patient examination gloves). The performance criteria and testing mentioned relate to the physical properties, biocompatibility, and acceptable quality levels (AQL) of the gloves, not to a digital algorithm or AI.
Therefore, many of the requested fields are Not Applicable in this context, as they pertain to the evaluation of AI/algorithm performance.
Here's a breakdown based on the provided information:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing (ASTM-D-5250-00E4) | All testing meets requirements. Inspection level S-2, AQL 4.0. |
| Pinhole Requirements (FDA 1000 ml. Water Fill Test) | Meets requirements. Samplings of AQL 2.5, inspection level I. |
| Primary Skin Irritation | No primary skin irritant reactions. |
| Skin Sensitization (allergic contact dermatitis) | No sensitization reactions. |
| Residual Powder (ASTM D6124-06 for Starch) | Meets "powder-free" claims (contains no more than 2 mg powder per glove). |
| Biocompatibility | Requirements met (implied by meeting skin irritation and sensitization tests, which are a part of biocompatibility assessment for surface-contacting devices). |
| Labeling (No special claims, not hypoallergenic) | Labeling claims met. |
| Conformance to ASTM D-5250-00E4 standard | Conforms fully. |
| Conformance to applicable 21 CFR references | Conforms fully. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set:
- For physical and dimensions testing: Inspection level S-2, AQL 4.0. (Specific sample size 'n' is not explicitly stated, but determined by an AQL table based on lot size and inspection level).
- For FDA 1000 ml. Water Fill Test: AQL 2.5, inspection level I. (Specific sample size 'n' is not explicitly stated).
- For Primary Skin Irritation and Skin Sensitization: Not specified.
- For Residual Powder Test: Not specified.
- Data Provenance: The tests were conducted by the manufacturer, Shijiazhuang Lianhe Shunda Plastic Products Co., Ltd., which is located in Shijiazhuang, Hebei, China. The testing would have been prospective to demonstrate compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This device is a physical product (gloves), not an AI/algorithm. Ground truth is established through standardized physical, chemical, and biological tests, not expert consensus in the diagnostic sense. The "experts" would be laboratory personnel skilled in performing these specific ASTM and FDA test methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 3. Testing involves objective measurements against established standards, not interpretation or adjudication of diagnostic findings.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is a physical product, not an AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical product, not an AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device is based on established industry standards and regulatory requirements:
- ASTM D-5250-00E4 standard specifications for vinyl patient examination gloves.
- FDA 1000 ml Water Fill Test for pinhole detection.
- ASTM D6124-06 for residual powder.
- Biocompatibility testing guidelines (e.g., ISO 10993 series, though not explicitly cited, these tests adhere to such principles).
8. The sample size for the training set
- Not Applicable. This is a physical product. There is no concept of a "training set" in the context of device testing for physical properties. Production processes are monitored using statistical process control, which might involve continuous sampling, but not in the "training set" sense of an algorithm.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
{0}------------------------------------------------
MAR 2 8 2007
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: _______________________________________________________________________________________________________________________________________________
l . Submitter's Identification:
Mr. Li Quanfu Shijiazhuang Lianhe Shunda Plastic Products Co., Ltd. Nanwuhui Village, Yuanshi County Shijiazhuang, Hebei, China 051130
Date Summary Prepared: September 20, 2006
2. Name of the Device:
Shijiazhuang Lianhe Shunda Plastic Products Co., Ltd. Powder Free (White) Vinyl Patient Examination Gloves
3. Predicate Device Information:
Shijiazhuang Great Eagle Plastic Products Co., Ltd Powder Free (White) Vinyl Patient Examination Gloves (K000071)
4. Device Description:
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Power-Free Vinyl Patient Examination Gloves, 80 LYZ, and meets all requirements of ASTM standard D-5250-00E4.
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.
{1}------------------------------------------------
6. Comparison to Predicate Devices:
Shijiazhuang Lianhe Shunda Plastic Products Co., Ltd.'s Powder Free (White) Vinyl Patient Examination Gloves is substantially equivalent in safety and effectiveness to the Shijiazhuang Great Eagle Plastic Products Co., Ltd.'s Powder-Free (White) Vinyl Patient Examination Gloves.
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as Follows:
The standards used for Shijiazhuang Lianhe Shunda Plastic Products Co., Ltd.'s glove production are based on ASTM-D-5250-00E4. 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 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 D6124-06 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:
Shijiazhuang Lianhe Shunda Plastic Products Co., Ltd.'s Powder Free (White) Vinyl Patient Examination Gloves conform fully to ASTM D-5250-00E4 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.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized image of an eagle with three heads, representing the department's focus on health, human services, and science. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle. The seal is simple and monochromatic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 8 2007
Shijiazhuang Lianhe Shunda Plastic Products Company Limited C/O Ms. Kathy Liu Official Correspondent Gloveco, Incorporated 3973 Schaefer Avenue Chino, California 91710
Re: K070041
Trade/Device Name: Powder Free (White) Vinyl Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: March 12, 2007 Received: March 13, 2007
Dear Ms. Liu:
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.
{3}------------------------------------------------
Page 2 - Ms. Liu
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Signature
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
{4}------------------------------------------------
Attachment A
INDICATION FOR USE
510 (k) NUMBER (IF KNOW): APPLICANT: DEVICE NAME:
ko10041 Shijiazhuang Lianhe Shunda Plastic Products Co., Ltd. Powder Free (White) Vinyl Patient Examination Gloves.
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 _X (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)
| (Division Sign-Off) |
|---|
| --------------------- |
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices510(k) Number: A070941
§ 880.6250 Non-powdered patient examination glove.
(a)
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.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.