(42 days)
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI or ML.
No.
The device, Powder Free Blue Patient Nitrile Examination Gloves, is intended to prevent contamination between patient and examiner, not to provide therapeutic benefit.
No
Explanation: The device is a glove intended to prevent contamination between patient and examiner, not to diagnose a medical condition.
No
The device is a physical product (gloves) and does not involve any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is a glove worn on the hand or finger to prevent contamination. It does not involve examining any bodily specimens.
- Intended Use: The intended use is to prevent contamination between patient and examiner, not to diagnose or provide information about a patient's health condition based on laboratory analysis.
The information provided confirms it's a medical device, but its function and intended use fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Powder Free Blue Patient Nitrile Examination Gloves 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.
Product codes
LZA
Device Description
Powder Free Blue Patient Nitrile Examination Gloves that meets all of the requirements of ASTM D 6139-05
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
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
Not Found
Summary of Performance Studies
Not Found
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
Summary
MAR 2 6 2007
"This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92."
"The assigned 510(k) number is: ______________________________________________________________________________________________________________________________________________
Premarket Notification [510(k)] Summary
[(a)(1)}. The summary contains on the first page, preferably on your letterhead paper, the submitter's name, address, phone and fax numbers, name of contact person, and date the summary was prepared :
| Submitter's name : | Tangshan Luxiong Plastic Products Co.,Ltd |
|---|---|
| Submitter's address : | Industrial Zone, Tanghai County, Tangshan, |
| Hebei , 063200, P. R. China | |
| Phone number : | (86)315-4169201 |
| Fax number : | (86)315-4169311 |
| Name of contact person: | Ms. Zhang Liang |
| Date the summary was prepared: | Feb.09.2007 |
[(a)(2)]. The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known
| Device Name: | Powder Free Blue Patient Nitrile Examination Gloves |
|---|---|
| Proprietary/Trade name: | Powder Free Blue Patient Nitrile Examination Gloves |
| Common Name: | Patient examination glove |
| Classification Name: | Patient examination glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital (80) |
| Product Code: | LZA |
[(a)(3)]. An identification of the legally marketed device to which your firm is claiming substantial equivalence .
Class I* Powder Free Blue Patient Nitrile Examination Gloves that meets all of the requirements of ASTM D 6139-05
Predicate device : Nitrile powder-free patient examination glove, JDA International Inc. K993247 .
|(a)(4){ A description of the device
Device Description : Powder Free Blue Patient Nitrile Examination Gloves that meets all of the requirements of ASTM D 6139-05
1
[(a)(5)] The summary describes the intended use of the device
Device Intended Use: Powder Free Blue Patient Nitrile Examination Gloves 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)(6)] A summary of the technological characteristics of new device compared to the predicate device.
The Powder Free Blue Patient Nitrile Examination Gloves, non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.
| Characteristics | Standard | Device performance |
|---|---|---|
| Dimension | ASTM D 6139-05 | Meets |
| Physical Properties | ASTM D 6139-05 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM D 5250-00c4 | |
| and D6124-01 | Meets | |
| Biocompatability | Primary Skin Irritation in rabbits | Passes |
| Not a Primary Skin Irritation | ||
| Dermal sensitization in the guinea pig | Passes | |
| Not a Dermal sensitization |
[(b)(1)] A brief discussion of the nonclinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence .
Powder Free Blue Patient Nitrile Examination Gloves meet requirements per ASTM D6319-05, per ASTM D6124-01, per 21 CFR 800.20 and ISO10993-10.
[(b)(2)] A brief discussion of the clinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence .
Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
[(b)(3)] The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe,as effective, and performed as well or better than the legally marketed device identified in (a)(3).
It can be concluded that the Powder Free Blue Patient Nitrile Examination Gloves meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL., meet labeling claims .
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 6 2007
Mr. Chu Xiaoan Official Correspondent Tangshan Luxiong Plastic Products Company, Limited Room 1606 Building 1, Jianxiang Yuan No. 209 Bei Si Huan Zhong Road Haidian District Beijing, China 100083
Re: K070404
Trade/Device Name: Nitrile Powder Free Blue Patient Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: February 9, 2007 Received: February 12, 2007
Dear Mr. Xiaoan:
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 -Mr. Xiaoan
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.
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
INDICATIONS FOR USE
Applicant: Tangshan Luxiong Plastic Products Co.,Ltd
510(k) Number (if known):_*
Device Name: Powder Free Blue Patient Nitrile Examination Gloves
Indications For Use:
Powder Free Blue Patient Nitrile Examination Gloves 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.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shule P. Murphy, M.D.
18 22 22 12 ം പങ്ങു Hospilal 3. 1964
- Number K07040