(74 days)
A patient examination glove is a disposable device intended for medical purposes worn on the hands to prevent contamination and eliminating contagious issue by the wearer. Suitable for use in medical examination, contagious issue by the world. In the dentistry field.
Patient Examination Glove Oleicon Powder free polymer coated berce Cot Bubblegum ssented NR latef
The provided text is a 510(k) premarket notification letter from the FDA regarding "Illusion Powder Free-Polymer Coated Bubble Gum Scented NR Latex Examination Gloves (Blue)". This document is a regulatory approval for a medical device and does not contain any information about a study proving the device meets acceptance criteria.
The FDA letter grants substantial equivalence based on the device's similarity to a legally marketed predicate device, not on specific performance studies detailed in this document. Therefore, I cannot provide the requested information.
The document indicates:
- Device Name: Illusion Powder Free-Polymer Coated Bubble Gum Scented NR Latex Examination Gloves (Blue)
- Regulation Number/Name: 880.6250 / Patient Examination Glove
- Regulatory Class: I
- Product Code: LYY
- Indications for Use: A disposable device intended for medical purposes worn on the hands to prevent contamination and eliminating contagious issue by the wearer. Suitable for use in medical examination and in the dentistry field.
To answer your specific questions, one would need access to the full 510(k) submission documentation, which would include the raw data and study reports if they were required and submitted. The letter itself only confirms the FDA's decision based on that submission.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 0 2 2004
Mr. Liew Yoon Fong Purnabina Sdn Bhd Plo 5, Jalan Mahsuri 1, 7.5 K.M. Jalan Mersing, Kawasan Perindustrian Kluang, 86007 Kluang, Johor Darul Takzim, MALAYSIA
Re: K041004
Trade/Device Name: Illusion Powder Free-Polymer Coated Bubble Gum Scented NR Latex Examination Gloves (Blue) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: April 15, 2004 Received: May 7, 2004
Dear Mr. Fong:
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.
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Page 2 - Mr. Fong
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), nlease contact the Office of Compliance at (301) 594-4618. 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 maj Sound 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/dsma/dsmamain.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
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- 3.0 Indications for Use Statement: Include the following or equivalent Indications for Use page. The information, data and labeling claims in the entire the 510(k) submission must support and agree with the Indications for Use statement.
INDICATIONS FOR USE
| Applicant: | Purnabina Sdn. bhd. |
|---|---|
| 510(k) Number (if known): | * K041004 |
| Device Name: | Patient Examination Glove Oleicon Powder free polymer coated berceCot Bubblegum ssented NR latef |
| Indications For Use: | |
| A patient examination glove is a disposable device intended for medical purposes worn on the hands to prevent contamination and eliminating contagious issue by the wearer. Suitable for use in medical examination, |
contagious issue by the world. In the dentistry field.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Saturn D.H. Kamin Medley Colony Branch
Aug 12/84
(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital, Division of Anesthoolors's
510(k) Number:
§ 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.