(45 days)
A Powder-free Vinyl Patient Examination Glove is disposable device made of PVC material that coated with PU coating to facilitate donning and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials individual contaminants.
The Powder-free vinyl exam glove is a disposable Class 1 medical device made from PVC material and is intended to be worn on the hands of health care personnel for medical purpose to provide a barrier against potentially infectious materials and other contaminants.
The provided documentation pertains to a 510(k) premarket notification for "Powder-Free Vinyl Exam Gloves" by SHANGHAI LANFAN CO., LTD. This document does not describe a study involving a device that analyzes data or provides diagnostic information. Instead, it concerns a Class I medical device (gloves) and demonstrates its substantial equivalence to predicate devices based on physical properties and biocompatibility. Therefore, most of the requested information regarding acceptance criteria and studies for device performance (especially for AI/software devices) is not applicable.
However, I can extract the relevant information regarding the glove's "acceptance criteria" through performance attributes and the testing conducted to meet those criteria.
1. A table of acceptance criteria and the reported device performance
For medical gloves, acceptance criteria typically relate to physical properties and barrier integrity. The document states that the device meets the "current Specifications listed under the ASTM D5250-06 Standard Specification for Vinyl Examination Gloves." While the specific values from ASTM D5250-06 are not detailed in this summary, the general categories of assessment are inferred.
| Acceptance Criteria (Inferred from ASTM D5250-06 and biocompatibility) | Reported Device Performance |
|---|---|
| Barrier Integrity (e.g., freedom from holes) | Meets ASTM D5250-06 Standard Specification. |
| Physical Dimensions (e.g., length, palm width, thickness) | Meets ASTM D5250-06 Standard Specification. |
| Physical Properties (e.g., tensile strength, elongation) | Meets ASTM D5250-06 Standard Specification. |
| Freedom from powder (for powder-free claims) | Confirmed as "Powder-free Vinyl Exam Gloves" and coated with PU for donning. |
| Biocompatibility (Primary Skin Irritation) | Indicates no irritation. |
| Biocompatibility (Delayed Contact Sensitization) | Indicates no sensitization. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for testing according to ASTM D5250-06. Such standards typically define sampling plans. The data provenance is China, as the submitter, SHANGHAI LANFAN CO., LTD, is located in Shanghai, China. The testing appears to be "retrospective" in the sense that it's standard quality control and product validation testing rather than a prospective clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. This device is a glove, and its performance is assessed via objective physical and chemical tests, not by expert interpretation of data.
4. Adjudication method for the test set
This question is not applicable as the performance is evaluated through objective measurements against established standards, not via expert adjudication.
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
This question is not applicable as the device is a medical glove, not an AI or diagnostic imaging device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a medical glove.
7. The type of ground truth used
For physical and chemical properties:
- Standard Specifications: ASTM D5250-06 "Standard Specification for Polyvinyl Examination Gloves for Medical Application" serves as the ground truth for acceptable performance limits and test methods for physical characteristics.
- Biocompatibility Testing Standards: Standards for Primary Skin Irritation (rabbit) and Delayed Contact Sensitization (guinea pig) serve as the ground truth for biocompatibility.
8. The sample size for the training set
This question is not applicable. There is no "training set" in the context of a medical glove. The product is manufactured and tested according to specified standards.
9. How the ground truth for the training set was established
This question is not applicable.
{0}------------------------------------------------
SHANGHAI LANFAN CO., LTD
202 Huaxia Bank Tower 256 Pudong Road South, Shanghai 200120 China Tel: +86-21-68865927 Fax: +86-21-68866351
ATTACHMENT IV: 510 (k) EXECUTIVE SUMMARY.
1072488
POWDER-FREE VINYL EXAMINATION GLOVE
UCT 1 9 2007
| Submitter's Name | Shanghai Lanfan Co., Ltd |
|---|---|
| Submitter's address | 2002 Huaxia Bank Tower 256 Pudong RoadSouth, Shanghai 200120 China |
| Submitter's Telephone Number | +86-21-68865927 |
| Submitter's Fax Number | +86-21-68866351 |
| Name of Contact Person | Kaifeng Bei |
| Date of Preparation | August 1, 2007 |
| Name of Device | Powder-free Vinyl Exam Gloves, |
| Trade Name | Lanfan Brand and other customers Privatelabeling |
| Common Name | Patient Examination Gloves, Vinyl |
| Classification Name | Patient Examination Gloves, VinylPowder-free (per proposed 21 CFR 880.6250) |
| Device Classification | Class I |
| Regulation Number | 21 CFR 880.6250 |
| Panel | General Hospital (80) |
| Product Code | LYZ |
| Device Description | The Powder-free vinyl exam glove is adisposable Class 1 medical device madefrom PVC material and is intended to beworn on the hands of health care personnelfor medical purpose to provide a barrieragainst potentially infectious materials andother contaminants. |
| Legally Marketed Device To WhichEquivalency is Being Claimed | Powder-free vinyl Exam gloves aredescribed in the 510 (k) notification aresubstantially equivalent to the Class I patientexamination gloves, Vinyl, 80LYZ Powderfree by PU coating, that meets the currentASTM D5250-06 "Standard Specification |
| Tel: +86-21-68865927 Fax: +86-21-68865927 | |
| for Polyvinyl Examination Gloves forMedical Application" | |
| Predicate Device | A) K070149 POWDER-FREE VINYLPATIENT EXAMINATION GLOVES,MANUFACTURED BY: WUXI SHENZHOUPLASTIC PRODUCTS CO., LTD. |
| B) K052985 POWDER FREE VINYLEXAMINATION GLOVEMANUFACTURED BY: TG MEDICAL(CHINA) INCORPORATION | |
| Summary of TechnologicalCharacteristics Compared to thePredicate DevicePerformance testing report | There are no different technologicalcharacteristics. Gloves are made from PVCmaterial. |
| Intended Use of the Device | Powder-free Vinyl Examination Glove isintended for single use for medical purposesand are worn on the hand of heath care andsimilar personnel to prevent contaminationbetween the health care personnel and thepatients. |
| Brief Discussion of Non clinical Tests | Testing is performed as per ASTMD5250-06 and 21 CFR 800.20, gloves meetall the current Specifications listed under theASTM D5250-06 Standard Specification forVinyl Examination Gloves.Primary Skin Irritation testing in the rabbitand delayed contact Sensitization testing inthe guinea pig indicate no irritation orsensitization. |
| Brief Discussion of Clinical Tests | No new clinical tests were conducted underthis 510 (k) |
| Conclusions Drawn for the Non clinicaland Clinical Tests | Non clinical Laboratory and animal dataindicate that the powder free vinyl glovemeet all performance and biocompatibilityrequirements. |
| Other Information Deemed Necessary byFDA | Non Applicable |
{1}------------------------------------------------
SHANGHAI LANFAN CO., LTD
202 Huaxia Bank Tower 256 Pudong Road South, Shanghai 200120 China Tel: + 86-21-68865927 Fax: + 86-21-68866351
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized representation of an eagle or bird-like figure with three horizontal lines above it, suggesting wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Bei Kaifeng Operation Manager Shanghai Lanfan Company, Limited 2002 Huaxia Bank Tower 256 Pudong Road South Shanghai 200120 CHINA
OCT 1 9 2007
Re: K072488
Trade/Device Name: Powder-Free Vinyl Exam Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: 1 Product Code: LYZ Dated: August 28, 2007 Received: September 6, 2007
Dear Bei Kaifeng:
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 premarketapproval 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 - Bei Kaifeng
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,
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}------------------------------------------------
SHANGHAI LANFAN
202 Huaxia Bank Tower 256 Pudong Road South, Shanghai 200120 China Tel: +86-21-68865927 Fax: +86-21-68866351
ATTACHMENT I:INDICATION FOR USE
Applicant:
Shanghai Lanfan Co., Ltd
2002 Huaxia Bank Tower 256 Pudong Road South
Shanghai, 200120 China
510 (K) NUMBER (IF KNOWN): _ KO12488
INDICATIONS FOR USE:
A Powder-free Vinyl Patient Examination Glove is disposable device made of PVC material that coated with PU coating to facilitate donning and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials individual contaminants.
吴开峰
Bei Kaifeng (Operation Manager)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE, IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) |
| (Division Sign Off) | |
|---|---|
| --------------------- | -- |
| Over-The-Counter-Use | X |
|---|---|
| ---------------------- | --- |
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices (Optional Format 1-2-96)
| 510(k) Number: | K970488 |
|---|---|
| ---------------- | --------- |
§ 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.