KEMENTERIAN KESEHATAN REPUBLIK INDONESIA

DIREKTORAT JENDERAL KEFARMASIAN DAN ALAT KESEHATAN

Jalan H.R. Rasuna Said Blok X-5 Kavling 4 - 9 Jakarta 12950
Telepon : (021) 5201590 Pesawat 2029, 8011
Faksimile : (021) 52964838 Kotak Pos : 203

Berdasarkan Peraturan Menteri Kesehatan R.I Nomor 62 Tahun 2017 Tentang Izin Edar Alat Kesehatan,
Alat Kesehatan Diagnostik In Vitro Dan Perbekalan Kesehatan Rumah Tangga dengan ini diberikan
persetujuan untuk diedarkan dengan :

NOMOR IZIN EDAR

ALAT KESEHATAN

KEMENKES RI AKD 10903710882

Nama Dagang / Merek : ABADA Powder Free Latex Medical Examination Gloves
Kelompok / Kelas Resiko : Non Elektromedik Non Steril / A

Kategori Produk : Peralatan Rumah Sakit Umum dan Perorangan

Sub Kategori : Peralatan Rumah Sakit Umum dan Perorangan Lainnya

Jenis Produk : Patient examination glove.

Tipe / Ukuran : XS, S, M, L, dan XL

Kemasan : Dus

Nama Produsen / Pabrikan : PT. HALONI JANE, Banten

Nama Pendaftar : PT. MUZAMAL VENTURES INDONESIA, Jawa Barat

Atas dasar lisensi dari : -

Ketentuan
1. Persetujuan izin edar berlaku sampai dengan 28 Februari 2027.
2. Wajib menyampaikan laporan berkala dan laporan jika ada kejadian yang tidak diinginkan akibat
penggunaan Alat Kesehatan tersebut di atas sesuai ketentuan berlaku.
3. Izin edar ini merupakan persetujuan perpanjangan dari Nomor Izin Edar Alat Kesehatan
KEMENKES RI AKD 10903710882 tanggal 11 Desember 2018. Dengan demikian izin edar
sebelumnya dinyatakan tidak berlaku.
4. Produsen hanya boleh menyalurkan produknya melalui Penyalur Alat Kesehatan (PAK).
5. Apabila dikemudian hari ada pihak lain yang berhak atas merek dan/atau keagenan produk
tersebut, pendaftar bersedia mengembalikan izin edar.
6. Penandaan dan informasi produk yang terlampir merupakan bagian yang tidak terpisahkan dari
persetujuan izin edar ini.
7. Apabila di kemudian hari terdapat kekeliruan, maka persetujuan izin edar ini akan ditinjau
kembali.

Jakarta, 10 Mei 2022

Dokumen ini telah ditandatangani secara elektronik menggunakan sertifikat elektronik yang diterbitkan BSrE.
 26 - Oktober - 2017
110 mm
110 mm
65 mm

65 mm
Latex Examination Powder Free

65 mm

P : 235 mm
L : 125 mm
T : 80 mm
KEMENKES RI AKD

Ruko Mega Grosir Cempaka Mas Blok | No 40 Jakarta

POWDER FREE LATEX MEDICAL EXAMINATION GLOVES

POWDER FREE LATEX MEDICAL EXAMINATION GLOVES

POWDER FREE LATEX MEDICAL EXAMINATION GLOVES

MUZAMAL VENTURES INDONESIA

Distributed By :

Pusat 10640

110 mm

Powder Free
Non - Sterile
INNERBOX
JI. Raya Serang Km 13.8 Cikupa, Tangerang
KAWASAN INDUSTRI TRISTATE,
Manufactured By :
PT . Haloni Jane
KEMENKES RI AKD

KEMENKES RI AKD

Latex Examination Powder Free

CAUTION :
This product contains natural rubber latex which may cause allergic reactions.
Other components used in the gloves may cause allergic reactions in some people.
If redness or irritation occurs, stop using these gloves. If you have skin allergies
65 mm

suspect you may be sensitized to natural rubber latex, do not use these gloves.
Consult with a dermatologist or physician. Exclude from latex free areas.

STORAGE :
Store in a dry, ventilated area. Avoid direct sunlight, fluorescent lighting, heat and
moisture. Do not store above 100° F (37° C)

HARSH CHEMICALS :
ABADA latex gloves provide an excellent biological barrier. They are not intendedt
to be used as a chemical barrier.

DISPOSAL :
Dispose of gloves and all biologically contaminated matter in the appropriate container.

DO NOT REUSE GLOVES.

 CAUTION :
This product contains natural rubber latex which may cause allergic reactions. Other
components used in the gloves may cause allergic reactions in some people. If
redness or irritation occurs, stop using these gloves. If you have skin allergies or
suspect you may be sensitized to natural rubber latex, do not use these gloves.
Consult with a dermatologist or physician. Exclude from latex free areas.
SIZE
STORAGE :
Store in a dry, ventilated area. Avoid direct sunlight, fluorescent lighting, heat and SIZE
moisture. Do not store above 100° F (37° C).
X-SMALL
HARSH CHEMICALS:
ABADA latex gloves provide an excellent biological barrier. They are not intended to
be used as a chemical barrier SMALL

240
DISPOSAL :
Dispose of gloves and all biologically contaminated matter in the appropriate MEDIUM
container.
Latex Gloves Latex Gloves
Exam Powder Free DO NOT REUSE GLOVES. Exam Powder Free
LARGE
Manufactured by
PT. HALONI JANE
Disposable Non-Sterile Cikupa - Tangerang 15710, Indonesia. Disposable Non-Sterile
Ambidextrous Beaded Cuff LOT No Ambidextrous Beaded Cuff X-LARGE
LOT
Mfg.NoDate 30 C

Mfg.
Exp.Date
Date
5C
Exp. Date
KEMENKES RI
Depkes RI Distributed By : PT. Muzamai Ventures Indonesia
Distributed By : PT. Muzamai Ventures Indonesia Made in Indonesia
QUANTITY : 10 BOXES

308 260

Project Name : Scale : Note :

Karton P : 38 cm
Non - Sterile L : 26 cm Date :
POWDER FREE T : 24 cm 26 - Oktober - 2017