(45 days)
No
The device is a disposable examination glove, and the description and testing focus on material properties and barrier function, with no mention of AI/ML.
No
The device is a medical glove intended to provide a barrier against contaminants, not to treat a disease or condition.
No
The device is a glove intended to provide a barrier against infectious materials, not to diagnose a medical condition.
No
The device is a physical glove made of PVC material, clearly described as a disposable Class 1 medical device intended to be worn on the hand. It does not involve any software components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is to provide a barrier against potentially infectious materials when worn on the hand or finger(s). This is a physical barrier function, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description reinforces the purpose as a barrier for healthcare personnel.
- Lack of IVD characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's condition.
- Anatomical Site: The anatomical site is the hand/finger, which is where the barrier is applied, not where a diagnostic sample would typically be taken or analyzed.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This glove does not fit that description.
N/A
Intended Use / Indications for Use
Powder-free Vinyl Examination Glove is intended for single use for medical purposes and are worn on the hand of heath care and similar personnel to prevent contamination between the health care personnel and the patients.
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.
Product codes
LYZ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands, hand or finger(s)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care personnel, heath care and similar personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Testing is performed as per ASTM D5250-06 and 21 CFR 800.20, gloves meet all the current Specifications listed under the ASTM D5250-06 Standard Specification for Vinyl Examination Gloves.
Primary Skin Irritation testing in the rabbit and delayed contact Sensitization testing in the guinea pig indicate no irritation or sensitization.
Summary of Performance Studies
Non clinical Laboratory and animal data indicate that the powder free vinyl glove meet all performance and biocompatibility requirements.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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 Road |
| South, 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 Private |
| labeling | |
| Common Name | Patient Examination Gloves, Vinyl |
| Classification Name | Patient Examination Gloves, Vinyl |
| Powder-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 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. | |
| Legally Marketed Device To Which | |
| Equivalency is Being Claimed | Powder-free vinyl Exam gloves are |
| described in the 510 (k) notification are | |
| substantially equivalent to the Class I patient | |
| examination gloves, Vinyl, 80LYZ Powder | |
| free by PU coating, that meets the current | |
| ASTM D5250-06 "Standard Specification | |
| Tel: +86-21-68865927 Fax: +86-21-68865927 | |
| for Polyvinyl Examination Gloves for | |
| Medical Application" | |
| Predicate Device | A) K070149 POWDER-FREE VINYL |
| PATIENT EXAMINATION GLOVES, | |
| MANUFACTURED BY: WUXI SHENZHOU | |
| PLASTIC PRODUCTS CO., LTD. | |
| B) K052985 POWDER FREE VINYL | |
| EXAMINATION GLOVE | |
| MANUFACTURED BY: TG MEDICAL | |
| (CHINA) INCORPORATION | |
| Summary of Technological | |
| Characteristics Compared to the | |
| Predicate Device | |
| Performance testing report | There are no different technological |
| characteristics. Gloves are made from PVC | |
| material. | |
| Intended Use of the Device | Powder-free Vinyl Examination Glove is |
| intended for single use for medical purposes | |
| and are worn on the hand of heath care and | |
| similar personnel to prevent contamination | |
| between the health care personnel and the | |
| patients. | |
| Brief Discussion of Non clinical Tests | Testing is performed as per ASTM |
| D5250-06 and 21 CFR 800.20, gloves meet | |
| all the current Specifications listed under the | |
| ASTM D5250-06 Standard Specification for | |
| Vinyl Examination Gloves. | |
| Primary Skin Irritation testing in the rabbit | |
| and delayed contact Sensitization testing in | |
| the guinea pig indicate no irritation or | |
| sensitization. | |
| Brief Discussion of Clinical Tests | No new clinical tests were conducted under |
| this 510 (k) | |
| Conclusions Drawn for the Non clinical | |
| and Clinical Tests | Non clinical Laboratory and animal data |
| indicate that the powder free vinyl glove | |
| meet all performance and biocompatibility | |
| requirements. | |
| Other Information Deemed Necessary by | |
| FDA | 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 |
|---|---|
| ---------------- | --------- |