(16 days)
Not Found
Not Found
No
The device is a standard examination glove with no mention of AI/ML capabilities or related performance metrics.
No.
The device, an examination glove, is intended for preventing contamination, not for treating a disease or condition.
No
Explanation: The device is a patient examination glove, described as preventing contamination. It does not perform any diagnostic function such as detecting, identifying, or monitoring a disease or condition.
No
The device is a physical examination glove, not a software application. The description clearly states it is a "disposable device intended for medical purpose that is worn on examiner's hand".
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between a patient and examiner by being worn on the examiner's hand. This is a physical barrier function, not a diagnostic test performed on a sample taken from the body.
- Device Description: It's a glove, a physical barrier.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The device is clearly described as a patient examination glove, which falls under the category of medical devices used for protection and hygiene, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Powder free Nitrile Examination Glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
A patient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
80 LZA, LZA
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Performance data is the same as mentioned immediately above.
We certify that our finished powder free nitrile examination gloves meet or exceed the ASTM D 6319-00ae2 Standard. Meets FDA pin hole requirement. Meets labeling claim.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
SEP 1 5 2005 .
PT. Shamrock Manufacturing Corpora
Jalan Pemuda No. 11, Medan-20151, N. Sumatra – Indonesia Ph. (+62-61) 455 8888 Fax. (+62-61) 452 0588 Email. smç@shamrock-id.com ==============================================================================================================================================================================
K052382 "510 (K)" SUMMARY
| (1) Name of applicant | : RUDI SALIM |
|---|---|
| Address | : PT. SHAMROCK Manufacturing Corp. |
| Jl. Pemuda No. 11 | |
| Medan 20151 - Indonesia | |
| Phone No. : 62-61-4558888 ,- 4558629, - 4520675 | |
| Fax No. : 62-61-4520588 | |
| Contact person in U.S.A | : Emmy Tjoeng |
| Phone No. | : 909-591-8855 |
| Fax No. | : 909-628-6283 |
| (2) Device details | |
| Trade Name | : Powder Free Nitrile Examination Gloves, Blue |
| Classification Name | : Powder Free Nitrile Examination Gloves, Blue |
| (3) Product Code | : 80 LZA |
| (4) Equivalent device legally marketed | : Class I Examination Gloves 80 LZA |
| meeting ASTM D 6319-00ae2 | |
| (5) Intended use | : Powder free Nitrile Examination Glove is a disposable |
| device intended for medical purpose that is worn on | |
| examiner's hand to prevent contamination between patient | |
| and examiner. |
1
| Technological characteristic of the gloves.) | ||||
|---|---|---|---|---|
| a. Dimension | Small | Medium | Large | X-Large |
| Length mm (min.) | 220 | 230 | 230 | 230 |
| Palm Width mm | $80\pm10$ | $95\pm10$ | $110\pm10$ | $120\pm10$ |
| Thickness |
- Cuff mm (min) | 0.08 | 0.08 | 0.08 | 0.08 |
| 2. Palm mm(min) | 0.08 | 0.08 | 0.08 | 0.08 |
| 3. Finger Tip mm | 0.08 | 0.08 | 0.08 | 0.08 |
| b. Physical Properties | Before ageing | | After ageing
at 70°C 168 hrs. | |
| Tensile Strength | : 14 Mpa (min) | | | 14 Mpa (min) |
| Ultimate Elongation | : 500 % (min.) | | | 400 % (min.) |
| c. Performance Requirement | | | | |
| Characteristic | Related Defects | | Inspection
Level | AQL |
| Freedom from holes | Holes | | I | 2.5 |
| Dimensions | Width Length
& Thickness | | S-2 | 4 |
| Physical Properties | Before and
after ageing | | S-2 | 4 |
| Powder-free Residue | Exceeds maximum limit | | N=5 | N/A |
| Powder Amount | Exceeds recommended
maximum limit | | N=2 | N/A |
- (6) T
- (7) Performance data is the same as mentioned immediately above.
- (8) Clinical date is not needed for gloves or for most devices cleared by the 510 (K) process.
- (9) Non-clinical data
We certify that our finished powder free nitrile examination gloves meet or exceed the ASTM D 6319-00ae2 Standard. Meets FDA pin hole requirement. Meets labeling claim.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a seal for the Department of Health and Human Services, USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a symbol that appears to be three stylized human profiles facing to the right, with flowing lines above and below them.
Public Health Service
SEP 1 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
PT. Shamrock Manufacturing Corp. C/O Ms. Emmy Tjoeng Shamrock Marketing Company, Inc. 5445 Daniels Street Chino, California 91710
Re: K052382
Trade/Device Name: Powder Free Nitrile Examination Glove, Blue Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: August 19, 2005 Received: September 1, 2005
Dear Ms. Tjoeng:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bectorn of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to regars than and the Medical Device Amendments, or to commerce prior to May 26, 1776, the encordance with the provisions of the Federal Food, Drug, devices that have occh reclassince in asses approval of a premarket approval application (PMA). and Cosment Act (Act) market the device, subject to the general controls provisions of the Act. The r ou may, ulercrore, market the Act include requirements for annual registration, listing of general controls provisions of the tice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it If your device is classified (500 above) als. Existing major regulations affecting your device can may be subject to such additional controliations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Outs neements concerning your device in the Federal Register.
3
Page 2 - Ms. Tjoeng
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loase be advised that I browner that your device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of ally Federal statutes and registanents, including, but not limited to: registration and listing (21 Comply with an the For 81 cFR Part 801); good manufacturing practice requirements as set CFR Part 607); adomig (Dr CFR Part 820); and if applicable, the electronic forth in the quant) by sections (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro herems (2005) - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 10 This letter will and will and with gof substantial equivalence of your device to a legally promaticated predicated. The Pro Massification 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 If you desire specific acriveliance at (240) 276-0115. Also, please note the regulation entitled, eonidor the office of Cremarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general miorinational 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
INDICATION FOR USE
| Applicant | : PT. Shamrock Manufacturing Corpora |
|---|---|
| 510(k) Number (if known): | K062382 |
| Device Name | : Powder Free Nitrile Examination Gloves, Blue |
| Indication for use | : |
A patient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand 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)
Shade A. Murphy, KG 9/15/05
ion Sign-Off) (Divis (Division of Anesthosiology, General Hospital, Infection Control. Dental
510(k) Number: `K052382