(85 days)
80LYZ
Not Found
No
The device description and intended use clearly define a standard vinyl patient examination glove, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is a patient examination glove used to prevent contamination, not to treat a medical condition.
No
Explanation: The device is a "Vinyl patient examination glove" which is used to prevent contamination, not to diagnose a medical condition.
No
The device is a physical glove, not software. The description clearly states it is a "Vinyl patient examination glove" and a "disposable device intended for medical purposes worn on the examiner's hand or finger".
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used externally during patient examination.
- IVD Definition: In vitro diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of bodily fluids, or diagnostic purposes related to analyzing samples in vitro (outside the body).
The device is a physical barrier for protection during examination, which falls under the category of general medical devices, not IVDs.
N/A
Intended Use / Indications for Use
A Vinyl patient examination glove is a disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Product codes
80LYZ
Device Description
Class I vinyl patient examination gloves 80LYZ,powdered,that meets all the requirements of ASTM D 5250-00.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Class I vinyl patient examination gloves 80LYZ, powdered, that meets all the requirements of ASTM D 5250-00.
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
TANGSHAN ZHONGHONG PULIN FOOD PRODUCTS CO.,LTD.
LUANNAN,TANGSHAN CITY,HEBEI PROVINCE,CHINA
Tcl: 86-315-4168379 Fax: 86-315-4168700
KO 22336
510 (k) SUMMARY
OCT 1 1 2002
- Submitter's name and address:
Baldur Systems Corporation
33235 Transit Avenue
Union City,CA 94587
Telephone and Fax numbers of submitter:
Tel:510-477-9194
Fax:510-477-9634
David Hu,Ph.d.,president Contact person:
l)ate summary prepared: April 30,2002
-
- Common name: Exam gloves
Classification name: Patient examination glove
- Common name: Exam gloves
-
- Legally marketed device:
Class I vinyl patient examination gloves
- Legally marketed device:
80LYZ,powdered,that meets all the requirements
of ASTM D 5250-00.
-
- Description of the device:
Class I vinyl patient examination gloves 80LYZ,powdered,that meets all the requirements of ASTM D 5250-00.
- Description of the device:
1
TANGSHAN ZHONGHONG PULIN FOOD PRODUCTS CO.,LTD. LUANNAN,TANGSHAN CITY,HEBEI PROVINCE,CHINA Tcl: 86-315-4168379 Fax: 86-315-4168700
EQUIVALENCE CLAIM
We claim that our gloves are equivalent to class I vinyl examination glove, product code 80LYZ,powdered,that meet all the requirements of ASTM standard D5250-00. For details please see bclow:
l ) Chemical data
Name of chemicals:
PVC resin
DOP(di-octyl-phthalate)
TXIB(2,2,4 trimthyl ,1,3 pentanediol,diisobutylate)
Epoxidized Soyabean Oil
Ca/Zn carboxylate stabilizer
2)Size specification and physical properties.
Please refer to attached sheet.(SPECIFICATION OF POWDERED
VINYL EXAMINATION GLOVFS,APRIL 30,2002)
- Pin Holc
3.1 Test method: use FDA 1000ml water leak test.
3.2 Sampling procedure and acceptance quality level.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Tangshan Zhonghong Pulin Food Products Company Limited C/O Mr. David Hu President HTI Trading Group 33235 Transit Avenue Union City, California 94587
OCT 11 2002
Re: K022336
Trade/Device Name: Vinyl Examination Gloves, Powdered Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: 80 LYZ Dated: September 11,2002 Received: October 1, 2002
Dear Mr. Hu:
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. Hu
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours.
Patina Curritiffor
Timothy A. Ulatowski 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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Page _ of _
| 510(k) Number (if known): | K022336 |
|---|---|
| Device Name: | Vinyl Exam Gloves, Powdered |
Indications For Use:
:
: 上一篇:
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:
and the control of the count
100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
A Vinyl patient examination glove is a disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE II NEEDED)
| Prescription Use | OR | Over-The-Counter Use X |
|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2 | |
| (Division Sign-Off) | ||
| Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | ||
| 510(k) Number: | K022336 |